FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K002061 |
A & D ENGINEERING, INC. |
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR |
01/19/2001 |
K761291 |
ABBOTT LABORATORIES |
CENTRAL STATION MONITORING SYSTEM |
12/28/1976 |
K760593 |
ABBOTT LABORATORIES |
PORTABLE CARDIAC MONITOR, ABBY |
09/16/1976 |
K811216 |
ABBOTT LABORATORIES |
RESIDENT BEDSIDE MONITOR |
07/02/1981 |
K801515 |
ABBOTT MEDICAL ELECTRONICS CO. |
ABBY II PATIENT MONITOR OR VITAL SIGNS M |
07/08/1980 |
K901031 |
ACCUCORE, INC. |
PCI MODEL 2041-PC TELEMETRY MONITOR |
05/17/1990 |
K010587 |
ACTIVE CORP. |
ACTIVEECG |
05/16/2001 |
K842462 |
ADVANTAGE MEDICAL SYSTEMS, INC. |
HOLTER SCREENING MONITOR HS-221 |
09/11/1984 |
K863494 |
ADVANTAGE MEDICAL SYSTEMS, INC. |
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 |
12/22/1986 |
K841363 |
AEQUITRON MEDICAL, INC. |
HEART RATE/RESPIRATION SIMULATOR 8310 |
10/02/1984 |
K842321 |
AIR-SHIELDS, INC. |
AIR SHIELDS AS461 MONITORING SYS |
08/03/1984 |
K972789 |
ALEXANDER MFG. CO. |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016 |
10/17/1997 |
K972787 |
ALEXANDER MFG. CO. |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P |
10/17/1997 |
K803223 |
AMERICAN EDWARDS LABORATORIES |
ADVANCMED ELIMINATOR |
01/13/1981 |
K874148 |
AMERICAN HEALTH PRODUCTS, INC. |
MONITRON SYSTEM |
06/15/1988 |
K941252 |
ANSAR |
RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR |
09/20/1995 |
K780297 |
ARCO MEDICAL PRODUCTS CO. |
CARDIAC MINISCOPE & MINIGRAPH |
05/19/1978 |
K934644 |
ASTRO-MED, INC. |
K3 SYSTEM |
11/01/1994 |
K830916 |
BIB, INC. |
VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR |
07/07/1983 |
K781387 |
BIO SIG INSTRUMENTS, INC. |
INSTA-PULSE HEART RATE MONITOR |
09/20/1978 |
K944257 |
BIO-TEK INSTRUMENTS, INC. |
LIONHEART 3 MULTI-PARAMETER SIMULATOR |
09/21/1994 |
K854639 |
BIOMECCA AUSTRALIA LTD. |
BIOMECCA CENTRAL CS1 |
04/17/1986 |
K831752 |
BIOTECHNOLOGY, INC. |
BIOCHECK PEC-108 PROGRAM-PULSE MONITOR |
09/29/1983 |
K851335 |
BIOTECHNOLOGY, INC. |
COACH TM- THE AEROBIC FITNESS MONITOR |
07/24/1985 |
K833594 |
BRENTWOOD INSTRUMENTS, INC. |
FUKUDA DENSHI FX-302 AUTO/THREE CHAN |
09/11/1984 |
K780702 |
BURDICK CORP. |
CSS-60 DIGITAL HEART RATE METER |
05/19/1978 |
K770239 |
BURDICK CORP. |
DIGITAL HEART RATE METER |
02/14/1977 |
K885085 |
BURDICK CORP. |
ERGOMED 840/ERGOMED 840L |
10/03/1989 |
K790292 |
BURDICK CORP. |
MONITOR, ELECTROCARDIOSCOPE |
02/26/1979 |
K821755 |
BURDICK CORP. |
TELCOR 2 |
07/02/1982 |
K790004 |
C-V MONITORS CORP. |
MONITOR SCOPES, MODELS 9502, 9503 |
02/28/1979 |
K861621 |
CARDIAC RECORDERS, LTD. |
CARDIAN II CR45A |
09/12/1986 |
K853673 |
CARDIAC RECORDERS, LTD. |
CARDIORATER CR 51 |
12/11/1985 |
K852910 |
CARDIAC RECORDERS, LTD. |
CARDIORATER CR7 |
11/19/1985 |
K852887 |
CARDIAC RECORDERS, LTD. |
CR5 CARDIAC MONITOR |
11/14/1985 |
K854041 |
CARDIO DISPLAY CORP. |
CD-100 CARDIAC MONITOR |
01/07/1986 |
K842582 |
CARE MONITORING SYSTEMS |
CARE 5000 CENTRAL MONITOR MS5220 ETC. |
12/11/1984 |
K821015 |
CARE MONITORING SYSTEMS |
CARE MODEL IP 4500 AUTO SCANNERR |
05/24/1982 |
K874844 |
CARE SYSTEMS, INC. |
CARE TELSTAT MODELS: MP 5010 AND MP 5020 |
02/09/1988 |
K790644 |
CHASE MFG. CO. |
"SUBMAX" |
04/26/1979 |
K051038 |
CIRITICARE SYSTEMS, INC. |
506 PATIENT MONITOR |
08/12/2005 |
K012763 |
COBE CARDIOVASCULAR, INC. |
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM |
11/15/2001 |
K890876 |
COLIN MEDICAL INSTRUMENTS CORP. |
BP-8800 BLOOD PRESSURE MONITOR |
06/22/1989 |
K863534 |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
LIFE-WATCH MONITOR LT-8 |
11/21/1986 |
K181165 |
Connected Sensing- A Division of Philips Medical Systems |
Philips wearable biosensor-G5 Solution |
03/07/2019 |
K832724 |
COPAL, INC. |
ACTIMETER UB-103 |
12/22/1983 |
K091050 |
CRITICARE SYSTEMS, INC. |
506CN PATIENT MONITOR |
05/27/2009 |
K910852 |
CRITICARE SYSTEMS, INC. |
507 NON-INVASIVE VITAL SIGNS MONITOR |
07/30/1991 |
K022435 |
CRITICARE SYSTEMS, INC. |
507EL VITAL SIGNS MONITOR |
08/14/2002 |
K843533 |
CRYO2 CORP. |
CARDIAC EVENT RECORDER |
06/28/1985 |
K781166 |
CYBERNETIC MEDICAL, INC. |
MONITOR, HEART RATE |
10/15/1978 |
K781407 |
CYNERGY |
ERM-101 |
09/27/1978 |
K800519 |
D. JENKINS |
HEARTWATCH |
09/26/1980 |
K802325 |
DART MEDICAL EQUIPMENT |
CRITERION II PACING SYSTEM MONITORS |
10/23/1980 |
K802782 |
DART MEDICAL EQUIPMENT |
THE CRITERION II PACING SYS. MONITOR |
11/19/1980 |
K812271 |
DATASCOPE CORP. |
CENTRAL STATION MONITOR |
08/31/1981 |
K911598 |
DATASCOPE CORP. |
DATASCOPE PASSPORT MONITOR |
10/15/1991 |
K772053 |
DATASCOPE CORP. |
LINE CHARGER MODEL LC-100 |
11/09/1977 |
K812828 |
DATASCOPE CORP. |
MODEL 2000 MONITOR |
11/16/1981 |
K974178 |
DATASCOPE CORP. |
PASSPORT 5L-CE MODEL 0998-00-0131XXX |
06/26/1998 |
K760803 |
DATASCOPE CORP. |
PHYSIOLOGICAL MONITOR (MODEL 870) |
10/20/1976 |
K772056 |
DATASCOPE CORP. |
PHYSIOLOGICAL MONITOR MODEL 871 |
11/22/1977 |
K897080 |
DATEX DIVISION INSTRUMENTARIUM CORP. |
CARDIOCAP(TM) CT-104 MONITOR |
03/06/1990 |
K981378 |
DATEX-ENGSTROM, INC. |
DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 |
11/03/1998 |
K850043 |
DEL MAR AVIONICS |
CARDIOGUARD STRESS TEST MONITOR 4002 |
02/08/1985 |
K813174 |
DOUGLAS SCIENTIFIC PRODUCTS |
BRADYCARDIA ALARM |
01/22/1982 |
K935817 |
DYNATECH/NEVADA, INC. |
MEDSIM 300 PATIENT SIMULATOR |
01/18/1994 |
K910870 |
EDENTEC CORP. |
EDENTEC MODEL 3711 DIGITAL RECORDER |
08/29/1991 |
K761076 |
ELDECO |
DEMODULATOR/CARDIOTACHOMETER |
12/28/1976 |
K823312 |
ELECTROMED INTL., LTD. |
CADIO-RESPIRATORY MONITOR #CR-2 |
11/30/1982 |
K821959 |
ELECTROMED INTL., LTD. |
CARDIO-RESPIRATORY MONITOR MODEL CR-1 |
07/20/1982 |
K812674 |
ELECTROMED INTL., LTD. |
INFANT CARIDAC MONITOR |
10/13/1981 |
K822319 |
ELECTRONIC MONITORS, INC. |
RE1000 HEART RATE MONITOR |
09/14/1982 |
K830795 |
ELECTRONICS FOR MEDICINE, INC. |
CABINET FOR MULTIPLE FUNCTION BLOCKS |
05/18/1983 |
K790198 |
ELECTRONICS FOR MEDICINE, INC. |
MONITOR PLUG-IN MODEL M1106 ECG |
03/06/1979 |
K790545 |
ENGINEERING DYNAMICS CORP. |
STRESS TESTING SYSTEM, LATERAL TILTING |
06/06/1979 |
K790544 |
ENGINEERING DYNAMICS CORP. |
STRESS TESTING SYSTEM, MULTI-POSITION |
06/05/1979 |
K030656 |
ENVAN, LLC |
ENVAN HEART RATE MONITOR |
04/08/2003 |
K121860 |
FLUKE BIOMEDICAL |
ESA615 |
01/25/2013 |
K121722 |
FLUKE BIOMEDICAL |
ESA620 ELECTRICAL SAFETY ANALYZER |
10/11/2012 |
K103336 |
FLUKE BIOMEDICAL |
MPS450 MULTIPARAMETER SIMULATOR |
04/13/2011 |
K110429 |
FLUKE BIOMEDICAL |
PROSIM 4, PROSIM 6, PROSIM 8 |
09/02/2011 |
K844348 |
FUKUDA DENSHI USA, INC. |
DYNASCOPE MONITOR DS-800 |
12/04/1984 |
K840055 |
FUKUDA DENSHI USA, INC. |
DYNASCOPE SERIES |
08/22/1984 |
K944262 |
FUKUDA DENSHI USA, INC. |
ECG MONITOR |
05/12/1995 |
K893405 |
FUKUDA DENSHI USA, INC. |
MODEL DS-504 DYNASCOPE PATIENT MONITOR |
10/02/1989 |
K903512 |
FUTURECARE SYSTEMS, INC. |
FUTURECARE CARELYNK IV SYSTEM |
07/18/1991 |
K812131 |
GAVON, INC. |
PORTAPULSE |
09/21/1981 |
K820416 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
#505 PORT. VITAL FUNCTIONS NEONATAL MON |
03/04/1982 |
K820417 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
#506 PORT. VITAL FUNCTIONS NEONATAL MON |
03/04/1982 |
K060307 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
12 RL ALGORITHM |
08/04/2006 |
K823904 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MODEL 515 NEO-TRAK NEONATAL MONITOR |
05/25/1983 |
K910665 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED |
12/31/1991 |
K833552 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
TREND PROCESSOR OPTION FOR #515 NEONAT |
01/27/1984 |
K912008 |
GENERAL DEVICES |
TRU-VIEW MULTI-CHANNEL DISPLAY |
10/09/1991 |
K801761 |
GENERAL ELECTRIC CO. |
PDS COMPUTER UNIT/VIDEO TERMINAL |
08/20/1980 |
K850113 |
GOULD, INC. |
C/PES 9103, ECG STRESS TESTING SYSTEM |
02/08/1985 |
K850114 |
GOULD, INC. |
C/PES 9201, ECG STRESS TESTING SYS |
02/22/1985 |
K830885 |
GOULD, INC. |
GOULD MODEL IM3000-IM3100 BATTERY POWER |
06/22/1983 |
K821942 |
HARVEY-BOSTWICK, INC. |
HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85 |
08/24/1982 |
K874695 |
HEALTHDYNE, INC. |
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900 |
01/29/1988 |
K892006 |
HEALTHDYNE, INC. |
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S |
05/23/1989 |
K033646 |
HEALTHFIRST CORP. |
TRIFIT 700 |
03/01/2005 |
K820825 |
HEWLETT-PACKARD CO. |
CARDIAC MONITOR - RATE ALARM |
04/15/1982 |
K771360 |
HEWLETT-PACKARD CO. |
ECG SCOPE MODEL 7833 |
08/04/1977 |
K921194 |
HEWLETT-PACKARD CO. |
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING |
11/09/1992 |
K911139 |
HEWLETT-PACKARD CO. |
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A |
06/11/1991 |
K761211 |
HEWLETT-PACKARD CO. |
MODEL 15050A DIGITAL DISPLAY |
12/13/1976 |
K842817 |
HEWLETT-PACKARD CO. |
MODEL 78353B |
06/06/1985 |
K822876 |
HEWLETT-PACKARD CO. |
MODEL 78534A PATIENT MONITOR |
10/18/1982 |
K790454 |
HEWLETT-PACKARD CO. |
MODEL 78801A PATIENT MONITORS |
04/03/1979 |
K900032 |
HEWLETT-PACKARD CO. |
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING |
04/10/1990 |
K821368 |
HEWLETT-PACKARD CO. |
MODELS 78504A & 78508A PATIENT MON. SYS |
05/25/1982 |
K770024 |
HEWLETT-PACKARD CO. |
MONITOR, NEONATAL, MODEL 78260A |
02/28/1977 |
K770022 |
HEWLETT-PACKARD CO. |
MONITOR, NEONATAL, MODEL 78261A |
02/28/1977 |
K770023 |
HEWLETT-PACKARD CO. |
MONITOR, NEONATE, MODEL 78213A |
02/28/1977 |
K760160 |
HEWLETT-PACKARD CO. |
MONITOR, PATIENT (MODEL 78333A) |
07/19/1976 |
K831787 |
HEWLETT-PACKARD CO. |
PATIENT MONITOR #78353A |
09/29/1983 |
K831944 |
HEWLETT-PACKARD CO. |
PATIENT MONITOR #78832A |
10/19/1983 |
K842236 |
HEWLETT-PACKARD CO. |
PATIENT MONITOR 78354A |
01/18/1985 |
K840251 |
HEWLETT-PACKARD CO. |
PATIENT MONITOR 78534B |
02/27/1984 |
K831943 |
HEWLETT-PACKARD CO. |
PATIENT MONITOR 788 33A |
10/19/1983 |
K822695 |
HEWLETT-PACKARD CO. |
SIGNAL DISTRIBUTION NETWORK #78581A |
10/15/1982 |
K052446 |
HOANA MEDICAL, INC. |
LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM |
02/02/2006 |
K100745 |
HOANA MEDICAL, INC. |
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM |
04/15/2010 |
K083534 |
HOANA MEDICAL, INC. |
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM |
04/13/2009 |
K082366 |
HOANA MEDICAL, INC. |
LIFEBED PATIENT VIGILANCE SYSTEM |
09/26/2008 |
K092037 |
HOANA MEDICAL, INC. |
LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM |
10/02/2009 |
K831818 |
HONEYWELL, INC. |
CENTRAL STATION MONITOR CSM-100 |
10/31/1983 |
K834530 |
HONEYWELL, INC. |
EXTENSION BOX EB200 |
06/01/1984 |
K831817 |
HONEYWELL, INC. |
PATIENT MONITOR #RM-100 |
10/31/1983 |
K831164 |
HONEYWELL, INC. |
PATIENT MONITOR CM 135 |
12/01/1983 |
K855125 |
HONEYWELL, INC. |
PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM |
03/26/1986 |
K830779 |
HONEYWELL, INC. |
PRESSURE FUNCTION BLOCK FOR BLOOD PRESS |
05/09/1983 |
K780445 |
HUGHES AIRCRAFT CO. |
LIQUID CRYSTAL DISPLAY DIGITAL WATCH |
06/19/1978 |
K802204 |
INDUSTRIAL & BIOMEDICAL SENSORS CORP. |
CT-1600 DIGITAL PULSE RATE MONITOR |
10/03/1980 |
K800405 |
INSTROMEDIX, INC. |
A-V MINI CLINIC |
07/21/1980 |
K853953 |
INSTRUMENTARIUM CORP. |
CARDIOCAP MONITOR |
06/02/1986 |
K823290 |
INTERMEDICS, INC. |
NEUROMEDICS PACETRON HEART RATE MONITOR |
12/30/1982 |
K974581 |
INVIVO RESEARCH, INC. |
MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT |
10/28/1998 |
K043354 |
INVIVO RESEARCH, INC. |
MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 |
01/10/2005 |
K936051 |
INVIVO RESEARCH, INC. |
OMNI-CENTRAL STATION MONITOR |
07/06/1994 |
K871149 |
IONTEC CORP. |
DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER |
06/05/1987 |
K151781 |
IVY BIOMEDICAL SYSTEMS INC. |
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor |
05/27/2016 |
K110987 |
IVY BIOMEDICAL SYSTEMS, INC. |
CARDIAC TRIGGER MONITOR |
07/22/2011 |
K170828 |
Ivy Biomedical Systems, Inc. |
Cardiac Trigger Monitor |
05/17/2017 |
K083854 |
IVY BIOMEDICAL SYSTEMS, INC. |
CARDIAC TRIGGER, MODEL: CTM300 |
02/13/2009 |
K880066 |
IVY BIOMEDICAL SYSTEMS, INC. |
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR |
03/22/1988 |
K884455 |
IVY BIOMEDICAL SYSTEMS, INC. |
MODEL 702 ECG/RESPIRATION/TEMPERATURE |
03/09/1989 |
K884096 |
IVY BIOMEDICAL SYSTEMS, INC. |
PATIENT MONITOR MODEL 701 |
02/23/1989 |
K023616 |
IVY BIOMEDICAL SYSTEMS, INC. |
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) |
11/04/2002 |
K091985 |
IVY BIOMEDICAL SYSTEMS, INC. |
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE |
07/24/2009 |
K914576 |
KELLER MEDICAL SPECIALTIES PRODUCTS, INC. |
KELLER CARDIAC MONITOR MEDIL KMS870 |
12/30/1991 |
K800500 |
KIRKLANDS SPORTING GOODS CO. |
PULSEOMETER |
04/08/1980 |
K822952 |
KONE INSTRUMENTS, INC. |
560 |
11/01/1982 |
K830432 |
KONE INSTRUMENTS, INC. |
CENTRAL STATION 590 |
03/24/1983 |
K863466 |
KONE INSTRUMENTS, INC. |
M700 STRESS MONITOR |
12/22/1986 |
K820540 |
KONE INSTRUMENTS, INC. |
OLLI 565 |
04/01/1982 |
K830433 |
KONE INSTRUMENTS, INC. |
PATIENT MONITOR 575 |
03/24/1983 |
K844733 |
KONTRON INSTRUMENTS, INC. |
KONTRON MINIMON 7131 PATIENT MONITOR |
03/27/1985 |
K844732 |
KONTRON INSTRUMENTS, INC. |
KONTRON MINIMON 7132 PATIENT MONITOR |
03/27/1985 |
K844215 |
KONTRON INSTRUMENTS, INC. |
KONTRON MINIMON 7134 PATIENT MONITOR |
04/04/1985 |
K844731 |
KONTRON INSTRUMENTS, INC. |
KONTRON SUPERMON 7210 PATIENT MONITOR |
05/16/1985 |
K883069 |
KONTRON INSTRUMENTS, INC. |
MINIMON 7134B PATIENT MONITOR |
01/17/1989 |
K883109 |
KONTRON, INC. |
MINIMON 7136B PATIENT MONITOR |
01/17/1989 |
K812145 |
LIFE SCIENCE INSTRUMENTATION, INC. |
CARDIORATER CR-3 |
09/25/1981 |
K812146 |
LIFE SCIENCE INSTRUMENTATION, INC. |
CARDIORATER CR-5 |
09/25/1981 |
K812147 |
LIFE SCIENCE INSTRUMENTATION, INC. |
CARDIORATER CR-7 |
09/25/1981 |
K812144 |
LIFE SCIENCE INSTRUMENTATION, INC. |
CENTERAL MONITOR 360 |
09/25/1981 |
K821223 |
LIFE SCIENCE INSTRUMENTATION, INC. |
CR-9 |
06/17/1982 |
K822388 |
LIFE SCIENCE INSTRUMENTATION, INC. |
LIFE TRACE 14 |
08/24/1982 |
K822390 |
LIFE SCIENCE INSTRUMENTATION, INC. |
LIFE TRACE 24 |
09/21/1982 |
K822389 |
LIFE SCIENCE INSTRUMENTATION, INC. |
LIFE TRACE 40/42 |
09/21/1982 |
K822615 |
LIFE SCIENCE INSTRUMENTATION, INC. |
LIFE WATCH LSI |
09/21/1982 |
K842037 |
LIFE SCIENCE INSTRUMENTATION, INC. |
LS 5 |
03/01/1985 |
K832016 |
LITTON MEDICAL ELECTRONICS |
LME HEART-RATE MONITOR |
10/26/1983 |
K834600 |
LITTON MEDICAL ELECTRONICS |
RECOMB ECG PREAMPLIFIER/206 069 03 |
06/01/1984 |
K832024 |
LITTON MEDICAL ELECTRONICS |
SERVOMED BASIC BEDSIDE UNIT - VARIOUS |
10/26/1983 |
K832250 |
LITTON MEDICAL ELECTRONICS |
SERVOMED BASIC BEDSIDE UNIT SMA 102- |
06/01/1984 |
K832026 |
LITTON MEDICAL ELECTRONICS |
SERVOMED BASIC BEDSIDE UNIT SMS 108 W/ |
10/26/1983 |
K840524 |
LITTON MEDICAL ELECTRONICS |
SERVOMED BASIC BEDSIDE UNIT SMV 110TP |
10/26/1984 |
K832131 |
LITTON MEDICAL ELECTRONICS |
SERVOMED CENTRAL STATION SMV 206 |
11/16/1983 |
K832018 |
LITTON MEDICAL ELECTRONICS |
SERVOMED COMPACT MONITOR 181/10105002 |
10/31/1983 |
K832021 |
LITTON MEDICAL ELECTRONICS |
SERVOMED COMPACT MONITOR SMK 154-8/101 |
11/16/1983 |
K840525 |
LITTON MEDICAL ELECTRONICS |
SERVOMED COMPACT MONITOR SMK 155-1/101 |
06/01/1984 |
K832025 |
LITTON MEDICAL ELECTRONICS |
SERVOMED COMPACT MONITOR SMK 155-7/101 |
03/22/1984 |
K832035 |
LITTON MEDICAL ELECTRONICS |
SERVOMED COMPACT MONITOR SMK 155-9 |
11/16/1983 |
K840521 |
LITTON MEDICAL ELECTRONICS |
SERVOMED DIGITAL DISPLAY MODULE |
06/01/1984 |
K840832 |
LITTON MEDICAL ELECTRONICS |
SERVOMED OXCARDIORE SPIROGRAPH 324/111 |
09/20/1984 |
K840523 |
LITTON MEDICAL ELECTRONICS |
SERVOMED PULSE AMPLIFIER MODULE-206- |
10/29/1984 |
K832041 |
LITTON MEDICAL ELECTRONICS |
SERVOMED STANDARD SMS 104 |
10/26/1983 |
K832095 |
LITTON MEDICAL ELECTRONICS |
SEVOMED COMPACT MONITOR SMK 154- |
03/22/1984 |
K920099 |
LUMISCOPE CO., INC. |
GYMMAN |
03/09/1992 |
K802182 |
LUNAR RADIATION CORP. |
WISCONSIN HEART RATE MONITOR |
10/31/1980 |
K830517 |
MARQUETTE ELECTRONICS, INC. |
CENTRAL STATION DISPLAY/RECORDER MATRIX |
06/15/1983 |
K952474 |
MARQUETTE ELECTRONICS, INC. |
EAGLE 3000 PATIENT MONITOR |
10/19/1995 |
K895801 |
MARQUETTE ELECTRONICS, INC. |
MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM |
04/04/1990 |
K872354 |
MARQUETTE ELECTRONICS, INC. |
SERIES 2000 BEDSIDE PATIENT MONITOR |
07/21/1987 |
K780117 |
MED GENERAL |
CARDIOMETER |
02/03/1978 |
K874319 |
MEDAC, INC. |
MONITOR, ELECTROGRAPHIC |
03/07/1988 |
K992413 |
MEDICAL DATA ELECTRONICS |
ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR |
08/19/1999 |
K930004 |
MEDICAL DATA ELECTRONICS |
ESCORT 100/300 SERIES B PATIENT MONITORS |
06/23/1993 |
K992411 |
MEDICAL DATA ELECTRONICS |
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR |
08/18/1999 |
K792312 |
MEDICAL DEVICES, INC. |
HEART RATE MONITOR MD-1 |
11/21/1979 |
K872249 |
MEDICAL ELECTRONICS LABORATORIES, INC. |
SIRECUST MODEL 960 AND 961 PATIENT MONITORING |
07/21/1987 |
K902608 |
MEDICAL SYSTEMS CORP. |
CARDIOMATIC MODEL MSC-1001 |
07/13/1990 |
K904353 |
MEDICAL SYSTEMS CORP. |
CARDIOMATIC MODEL MSC-2001 |
12/20/1990 |
K823197 |
MEDICON, INC. |
MODEL 8300 TESTER |
12/30/1982 |
K820671 |
MEDTEL PTY. LTD. |
CM10 CENTRAL MONITORING SYSTEM |
04/01/1982 |
K800243 |
MEDTEL PTY. LTD. |
D668 & D664 CENTRAL MONITORING SYSTEMS |
04/10/1980 |
K802184 |
MEDTEL PTY. LTD. |
HS10 PORTABLE OPERATING ROOM MONITOR |
09/26/1980 |
K820399 |
MEDTEL PTY. LTD. |
HS20 PORT. OPERATING ROOM MONITOR |
03/22/1982 |
K850135 |
MEDWATCH SYSTEMS, INC. |
MEDWATCH 400 CARDIAC CENTRAL NURSES STATION |
05/16/1985 |
K850880 |
MENNEN MEDICAL, INC. |
HORIZON 1000 CARDIAC MONITOR |
04/25/1985 |
K892066 |
MENNEN MEDICAL, INC. |
HORIZON CENTRAL STATION |
06/22/1989 |
K911616 |
MENNEN MEDICAL, INC. |
HORIZON XL |
07/10/1991 |
K940081 |
MENNEN MEDICAL, INC. |
MERCURY |
04/12/1995 |
K851325 |
MICROCOR, INC. |
MICROCOR ECG MONITOR |
05/21/1985 |
K895534 |
MICROMEDICAL |
BIOLOG |
03/19/1990 |
K915624 |
MICROMEDICAL INDUSTRIES, LTD. |
MODIFIED BIOLOG |
03/27/1992 |
K850619 |
MIDWEST ANALOG & DIGITAL, INC. |
BEDSIDE PATIENT MONITOR W/MODULES |
06/06/1985 |
K853757 |
MOLDTEC, INC. |
MOLDTEC STIMULATOR |
02/28/1986 |
K902652 |
MORTARA INSTRUMENT, INC. |
MORTARA INSTRUMENT MODEL ELI 50 |
08/23/1990 |
K965158 |
N.P.N.T., INC. |
HEART PROTECTOR (VER 1996) |
12/09/1997 |
K792117 |
NARCO AIR-SHIELDS |
AIR-SHIELDS HEART RATE MONITOR |
11/13/1979 |
K790552 |
NARCO AIR-SHIELDS |
AS7 & AS8 MONITORS |
05/01/1979 |
K820114 |
NARCO AIR-SHIELDS |
SYSTEM V.HEART RATE/RESPIR. RATE MONIT. |
02/12/1982 |
K831430 |
NARCO SCIENTIFIC |
AIR SHIELDS AS-100 MONIORING SYS-AS105 |
09/12/1983 |
K831428 |
NARCO SCIENTIFIC |
AS 1740 INTERFACE MODULE |
10/14/1983 |
K960544 |
NASIFF ASSOC., INC. |
CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM |
08/07/1996 |
K952790 |
NIAN-CRAE, INC. |
LOG-A-RYTHM MODEL 100 AND MODEL 1001 |
10/17/1996 |
K844911 |
NIHON KOHDEN AMERICA, INC. |
ARRHYTHMIA CENTRAL-OGP-7201 |
01/18/1985 |
K841501 |
NIHON KOHDEN AMERICA, INC. |
LIFESCOPE 6 OEC-6102 |
08/28/1984 |
K841502 |
NIHON KOHDEN AMERICA, INC. |
LIFESCOPE 6 OEC-6105 |
08/28/1984 |
K862463 |
NIHON KOHDEN AMERICA, INC. |
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC |
12/05/1986 |
K841499 |
NIHON KOHDEN AMERICA, INC. |
LIFESCOPE II |
08/28/1984 |
K901034 |
NIHON KOHDEN AMERICA, INC. |
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL |
04/19/1990 |
K973918 |
NIHON KOHDEN AMERICA, INC. |
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES |
01/13/1998 |
K813444 |
NIHON KOHDEN AMERICA, INC. |
NIHON KOHDEN HEART MONITORS OMP 7101-02 |
12/29/1981 |
K043517 |
NIHON KOHDEN AMERICA, INC. |
TRANSMITTER, ZS-940PA SERIES |
02/03/2005 |
K904696 |
NIHON KOHDEN AMERICA, INC. |
WEP-8430A TELEMETRY CENTRAL STATION |
02/07/1991 |
K894919 |
NIRAD LTD. |
NR5000 E.C.G. AND PULSE OXIMETER MONITOR |
09/18/1989 |
K840560 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
NEONATAL PHYSIOLOGICAL MONITOR 903 |
04/17/1984 |
K811893 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
NOVAMETRIX PHYSIOLOGICAL MONITOR #910 |
09/08/1981 |
K821720 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000 |
06/25/1982 |
K831578 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
PHYSIOLOGICAL MONITOR #902 |
08/12/1983 |
K905274 |
PACE TECH, INC. |
VITALMAX 2100/2200 |
07/17/1991 |
K900451 |
PACE TECH, INC. |
VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE |
07/18/1990 |
K792226 |
PARAMED TECHNOLOGY, INC. |
CARDIVAN BLOOD PRESSURE MONITOR |
12/19/1979 |
K772006 |
PHYSIO-CONTROL CORP. |
ACUTE CARDIAC CARE SYSTEM |
11/28/1977 |
K830587 |
PHYSIO-CONTROL CORP. |
VITAL SIGNS MONITOR 2 |
06/08/1983 |
K851916 |
PHYSIO-CONTROL CORP. |
VSM MODELS A & B |
08/19/1985 |
K854847 |
PHYSIO-DYNE INDUSTRUMENT CORP. |
PHYSIO-DYNE ECG/HR 3 |
06/16/1986 |
K880498 |
PPG INDUSTRIES, INC. |
RM-301 PATIENT MONITOR |
05/13/1988 |
K063735 |
PRESYM, INC. |
PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 |
09/19/2007 |
K884804 |
PROMARK, INC. |
THE COACH |
05/19/1989 |
K002725 |
PROTOCOL SYSTEMS, INC. |
MICROPAQ, MODELS 402 AND 404 |
11/21/2000 |
K910882 |
PROTOCOL SYSTEMS, INC. |
PROPAQ 102EL, 104EL AND 106EL |
05/08/1991 |
K884320 |
PROTOCOL SYSTEMS, INC. |
PROPAQ 106(TM) |
12/27/1988 |
K945071 |
PROTOCOL SYSTEMS, INC. |
PROPAQ 200 MONITOR |
05/10/1995 |
K811425 |
PULSE TIME PRODUCTS, LTD. |
CARDIACMONITORS |
09/16/1981 |
K864748 |
PULSE TIME PRODUCTS, LTD. |
PM-8 HEART RATE MONITOR |
03/20/1987 |
K892794 |
PULSE TIME PRODUCTS, LTD. |
PULSE TIME PRODUCTS LIMITED, PM-2 |
08/25/1989 |
K892795 |
PULSE TIME PRODUCTS, LTD. |
PULSE TIME PRODUCTS LIMITED, PM-3 |
08/25/1989 |
K872443 |
PURITAN BENNETT CORP. |
COMPANION 50 REGULATOR/FLOWMETER |
07/21/1987 |
K820745 |
PURITAN BENNETT CORP. |
DIASCOPE 2 |
04/01/1982 |
K853318 |
PURITAN BENNETT CORP. |
PATIENT MONITOR PB240 |
03/11/1986 |
K854198 |
QUANTUM LIFE SYSTEMS, INC. |
PE-3000 PULSE RATE MONITOR |
03/13/1986 |
K780404 |
QUINTON, INC. |
ECG MONITORING SYSTEM, |
03/28/1978 |
K772097 |
QUINTON, INC. |
HEARTRATE METER MODEL 650, P/N 000119 |
11/22/1977 |
K781255 |
RAE MEDICAL CORP. |
DIGITAL PANEL METER |
09/20/1978 |
K770038 |
RESPIRONICS, INC. |
MONITOR, HEARTWATCH HEART RATE |
01/14/1977 |
K843376 |
RIGEL MEDICAL ELECTRONICS, INC. |
ECG PATIENT MONITOR |
12/27/1984 |
K850156 |
RIGEL MEDICAL ELECTRONICS, INC. |
ECG PATIENT MONITOR 301 |
03/01/1985 |
K850155 |
RIGEL MEDICAL ELECTRONICS, INC. |
ECG PATIENT MONITOR 302 |
03/01/1985 |
K850407 |
RIGEL MEDICAL ELECTRONICS, INC. |
NEONATAL MONITOR 309 |
04/18/1985 |
K884645 |
RIGEL MEDICAL ELECTRONICS, INC. |
PATIENT MONITOR RIGEL MODEL MULTICARE 429 |
02/02/1989 |
K875160 |
RIGEL MEDICAL ELECTRONICS, INC. |
RIGEL MODEL MULTICARE 409 |
06/28/1988 |
K840717 |
ROBERT BOSCH CORP. |
ECS 502 |
08/19/1985 |
K854491 |
ROBERT BOSCH CORP. |
ERG 550 ERGOMETER BICYCLE |
06/16/1986 |
K854492 |
ROBERT BOSCH CORP. |
ERG 551 ERGOMETER, BICYCLE |
06/16/1986 |
K854493 |
ROBERT BOSCH CORP. |
ERG 555 COUCH ERGOMETER |
06/16/1986 |
K782089 |
ROCHE MEDICAL ELECTRONICS, INC. |
MONITOR, HEART RATE MODEL 103 |
01/04/1979 |
K782088 |
ROCHE MEDICAL ELECTRONICS, INC. |
MONITOR, HEART RATE MODEL 105 |
01/04/1979 |
K833689 |
S & W MEDICO TEKNIK |
DIASCOPE 2 |
10/26/1984 |
K912049 |
S & W MEDICO TEKNIK |
SYSTEM ATHENA - PRODUCT ENHANCEMENTS |
12/05/1991 |
K911611 |
S & W MEDICO TEKNIK |
SYSTEM ATHENA, MODIFICATION |
02/05/1993 |
K896699 |
S & W MEDICO TEKNIK |
TYPE 9040/NEO |
04/20/1990 |
K894699 |
S & W MEDICO TEKNIK |
TYPE 9140 (SYSTEM ATHENA) |
10/02/1989 |
K896700 |
S & W MEDICO TEKNIK |
TYPE 9140/NEO |
04/20/1990 |
K884117 |
S & W MEDICO TEKNIK |
TYPE 9210 ECG SYSTEM ATHENA |
04/26/1989 |
K894700 |
S & W MEDICO TEKNIK |
TYPE PDU/CDU 9040 (SYSTEM ATHENA) |
10/02/1989 |
K950688 |
SAFETY TEK CORP. |
OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM |
04/18/1996 |
K822692 |
SANYO ELECTRIC, INC. |
DIGITAL PULSE METER (73 BWS) #HRM-100E |
10/15/1982 |
K850449 |
SANYO ELECTRIC, INC. |
DIGITAL PULSE METER HRM-100E & ETC. |
12/04/1986 |
K963576 |
SCIENTIFIC APPLICATIONS |
MOBILE MEDICAL MONITOR (M3(A)) |
02/28/1997 |
K943242 |
SENSOR DYNAMICS, INC. |
PRO-SPORT HEART RATE MONITOR |
03/10/1995 |
K943243 |
SENSOR DYNAMICS, INC. |
PULSE HEART RATE MONITOR |
03/10/1995 |
K780937 |
SENTRONIX, INC. |
MODEL 20 DIGITAL PULSE RATE MONITOR |
08/31/1978 |
K032733 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
PM-8000 PATIENT MONITOR, MODEL 8000 |
03/03/2004 |
K020144 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SIEMENS INFINITY SC 6002XL MODIFICATIONS |
02/15/2002 |
K844187 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SIEMENS SIRECUST 404N NEONATAL MONITOR |
04/11/1985 |
K854881 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SIRECUST 341 AND 341R |
03/11/1986 |
K790506 |
SIMONSEN & WEELS EFTF. |
DAISCOPE & ACCESSORIES |
04/09/1979 |
K760120 |
SPACELABS, INC. |
PULSE CARDULE (MODEL 1859/1860 ECG) |
07/20/1976 |
K844888 |
SPACELABS, INC. |
SPACELABS SERIES 600 PATIENT MONITORS |
02/01/1985 |
K791862 |
STANFORD ASSOC., INC. |
HEART RATE COMPUTER |
10/04/1979 |
K792122 |
STANFORD SCIENTIFIC, INC. |
CHRONAEROBIC (CA-1) |
11/27/1979 |
K781292 |
STREET ELECTRONICS CORP. |
CARDIOPNEUMOGRAPH |
09/20/1978 |
K771199 |
STRYKER CORP. |
SURGIPULSE HEART RATE MONITOR |
07/25/1977 |
K934684 |
TECHNOLOGY TRANSFER, INC. |
PAM CARDIAC MONITOR |
10/17/1994 |
K772332 |
TELECTRONICS, INC. |
MONITOR, CARDIAC, BEDSIDE |
02/13/1978 |
K760710 |
TIME COMPUTER, INC. (TCI) |
PULSAR PULSE MONITOR WATCH |
12/02/1976 |
K782131 |
VAN, COTT, BAGLEY, CORNWALL & MCCARTH |
PULSETAKER |
01/15/1979 |
K854597 |
VICKERS LTD. |
VICKERS MEDICAL MODEL 271 HEART RATE MONITOR |
05/09/1986 |
K926298 |
VIDCO, INC. |
520 DISPLAY DRIVER- STATUS I |
05/04/1994 |
K150992 |
VIOS MEDICAL, INC. |
Vios Monitoring System |
12/16/2015 |
K172586 |
Vios Medical, Inc. |
Vios Monitoring SystemÖ Model 2050 |
06/22/2018 |
K810755 |
VITATEK |
SQUINN VITATEK 500 SERIES PHYSIOL. MONI |
04/03/1981 |
K882609 |
WALTHAM DIV. HEWLETT PACKARD |
MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM |
01/19/1989 |
K830282 |
WALTON MANUFACTURER CO. |
ELECTRONIC EXERCISE #313-PULSE RATE |
04/14/1983 |
K021681 |
WELCH ALLYN PROTOCOL, INC. |
MICROPAQ, MODELS 402, 404 |
07/23/2002 |
K012451 |
WELCH ALLYN PROTOCOL, INC. |
PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 |
08/20/2001 |
K984033 |
WELCH ALLYN, INC. |
ATLAS MONITOR |
07/08/1999 |
K082626 |
WIRELESS 2000 RF & UWB TECHNOLOGIES LTD. |
PAM 3000 |
01/16/2009 |
K092809 |
WR MEDICAL ELECTRONICS CO. |
HRV ACQUIRE |
10/19/2010 |
K001775 |
ZOE MEDICAL, INC. |
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM |
01/12/2001 |
K102174 |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
ZOLL PROPAQ M |
09/15/2010 |