FDA 510(k) Applications for Medical Device Product Code "DRT"
(Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))

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
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
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