FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K914273 |
A & D ENGINEERING, INC. |
A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR |
02/09/1993 |
K871718 |
A & D ENGINEERING, INC. |
MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER |
06/24/1987 |
K871720 |
A & D ENGINEERING, INC. |
MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER |
07/29/1987 |
K880079 |
A & D ENGINEERING, INC. |
TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420 |
03/31/1988 |
K874338 |
A & D ENGINEERING, INC. |
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610 |
02/05/1988 |
K874339 |
A & D ENGINEERING, INC. |
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620 |
12/18/1987 |
K802600 |
AMERICAN MEDICAL PRODUCTS, INC. |
AMP PORTABLE PATIENT PRESSURE MONITOR |
11/12/1980 |
K801110 |
AMERICAN OPTICAL CORP. |
PRESSURE MONITOR, MODEL 1131B |
05/20/1980 |
K771772 |
APPLIED MEDICAL RESEARCH |
DINAMAP MODEL 825A |
10/04/1977 |
K781053 |
APPLIED MEDICAL RESEARCH |
DINAMAP MODEL 846 |
09/07/1978 |
K781064 |
APPLIED MEDICAL RESEARCH |
DINAMAP MODEL 848 |
09/07/1978 |
K782073 |
APPLIED MEDICAL RESEARCH |
DINAMAP MODELS 1160 AND 1165 |
02/23/1979 |
K771981 |
APPLIED MEDICAL RESEARCH |
MINIMAP MODEL 810 |
01/24/1978 |
K844396 |
ASSOCIATED MILLS, INC. |
POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 |
04/18/1985 |
K844397 |
ASSOCIATED MILLS, INC. |
POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 |
04/18/1985 |
K080670 |
ATCOR MEDICAL |
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM |
04/23/2008 |
K070795 |
ATCOR MEDICAL PTY. LTD |
SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM |
08/31/2007 |
K921388 |
BIOCHEM INTERNATIONAL, INC. |
BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE |
05/26/1993 |
K912833 |
CAMINO LABORATORIES, INC. |
CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY |
09/23/1991 |
K893232 |
CAMINO LABORATORIES, INC. |
MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM |
07/14/1989 |
K811079 |
CARDIODYNE GENERAL, INC. |
SYPHGMOLOG |
06/12/1981 |
K790135 |
CONCEPT, INC. |
MONITOR, PRESSURVEIL |
02/13/1979 |
K943457 |
DATEX DIVISION INSTRUMENTARIUM CORP. |
AS/3 PRESSURE TEMPERATURE MODULE, M-PT |
07/27/1994 |
K882093 |
DATEX DIVISION INSTRUMENTARIUM CORP. |
CARDIOCAP(TM) CMO-104 MONITOR |
07/28/1988 |
K862455 |
DATEX DIVISION INSTRUMENTARIUM CORP. |
MODIFIED CARDIOCAP MONITOR |
09/24/1986 |
K792077 |
DEL MAR AVIONICS |
MODEL 1981 PRESSUROMETER DATA ANALYSIS |
12/04/1979 |
K160945 |
ENDOPHYS HOLDINGS, LLC |
Endophys Blood Pressure Monitor |
09/26/2016 |
K141615 |
ENDOPHYS, INC. |
ENDOPHYS BLOOD PRESSURE MONITOR |
01/07/2015 |
K831481 |
EUGENE SCARBERRY |
DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN |
10/04/1983 |
K003122 |
FLORENCE MEDICAL LTD. |
SMARTFLOW, MODEL SFIP 2000 |
05/14/2001 |
K862200 |
FORTEC ELECTRONIC CORP./NAM TAI |
FORTEC MI-100, BLOOD PRESSURE METER |
11/18/1986 |
K822843 |
GLOBAL OFFICE AUTOMATION SYSTEM, INC. |
HTS *1 |
12/15/1982 |
K780798 |
GOULD, INC. |
GOULD-STATHAM SP1405 PRESSURE MONITOR |
06/13/1978 |
K772234 |
HEWLETT-PACKARD CO. |
CARDIAC OUTPUT MODULE-78231C |
01/05/1978 |
K822878 |
HEWLETT-PACKARD CO. |
MODEL 78553A PRESSURE PLUG-IN MODULE |
10/18/1982 |
K810179 |
HONEYWELL, INC. |
DUAL TRACE PATIENT MONITOR 116,118,120 |
02/25/1981 |
K810178 |
HONEYWELL, INC. |
PATIENT MONITOR CM111, 112 |
02/25/1981 |
K810171 |
HONEYWELL, INC. |
PERIPHERAL PULSE FUNCTION BLOCKS |
02/25/1981 |
K810172 |
HONEYWELL, INC. |
PRESSURE FUNCTION BLOCKS |
02/25/1981 |
K771977 |
INSTRUMENTATION LABORATORY CO. |
CARDIAC OUTPUT COMPUTER MODEL 701 |
01/03/1978 |
K862647 |
IVY BIOMEDICAL SYSTEMS, INC. |
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 |
08/18/1986 |
K802925 |
LIFECARE SERVICES, INC. |
6-415 FILTER, ELEMENT, 170-C |
12/19/1980 |
K832017 |
LITTON MEDICAL ELECTRONICS |
LME BLOOD PRESSURE MONITOR |
10/31/1983 |
K983250 |
MAGNETIC RESONANCE EQUIPMENT CORP. |
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR |
12/12/1999 |
K791839 |
MEDTEL PTY. LTD. |
H59 CRITICAL CARE MONITOR |
10/01/1979 |
K791838 |
MEDTEL PTY. LTD. |
HSH/H512 ADULT PHYSIOLOGICAL MONITORS |
10/01/1979 |
K850879 |
MENNEN MEDICAL, INC. |
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR |
04/25/1985 |
K873765 |
NAM TAI LTD. |
FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER |
10/09/1987 |
K800360 |
OUTPUT, INC. |
OUTPUT DIGITAL DISPLAY MODULE, MOD. 611 |
02/29/1980 |
K780356 |
OUTPUT, INC. |
OUTPUT DIGITAL DISPLAY MODULE, MODEL 401 |
05/31/1978 |
K896535 |
OXFORD MEDILOG, INC. |
MEDILOG OPTIMA |
01/18/1990 |
K951226 |
PACE TECH, INC. |
VITALMAX 4000/MINIPACK 3100/3000 |
11/21/1996 |
K903900 |
PPG HELLIGE B.V. |
SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD. |
01/08/1991 |
K901514 |
PPG INDUSTRIES, INC. |
XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS. |
11/16/1990 |
K882085 |
PROTOCOL SYSTEMS, INC. |
PROPAQ 104(TM) |
07/28/1988 |
K002742 |
PWV MEDICAL PTY, LT. |
SPHYGMOCOR MX MODEL SCOR-MX |
05/01/2001 |
K002067 |
RADI MEDICAL SYSTEMS AB |
RADIANALYZER, MODEL 12710 |
01/11/2001 |
K013943 |
RADI MEDICAL SYSTEMS AB |
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 |
12/18/2001 |
K021517 |
ROZINN ELECTRONICS, INC. |
ABP FOR WINDOWS |
07/24/2002 |
K912816 |
S & W MEDICO TEKNIK |
PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE |
04/10/1992 |
K884118 |
S & W MEDICO TEKNIK |
TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA |
04/25/1989 |
K033738 |
SCHILLER AG |
MONITORING SYSTEM, MODEL ARGUS PB-2200 |
08/24/2004 |
K781701 |
SEARS, ROEBUCK & CO. |
BLOOD PRESSURE, DIGITAL MODEL #2153 |
12/04/1978 |
K810635 |
SEARS, ROEBUCK & CO. |
ELECTRODE BLOOD PRESSURE MONITOR |
05/08/1981 |
K863042 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR |
01/14/1987 |
K860689 |
SPACELABS, INC. |
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE |
07/30/1986 |
K885235 |
SPECTRAMED, INC. |
SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. |
01/25/1989 |
K772334 |
TELECTRONICS, INC. |
MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP |
02/21/1978 |
K884938 |
TICO MEDICAL INSTRUMENTS, INC. |
VITAL SIGNS MONITOR |
04/19/1989 |
K811148 |
VIAT-STAT |
VITA-STAT MODEL 9000-S |
06/30/1981 |
K811146 |
VITA-STAT |
VITA-STAT MODEL 8000-C |
06/30/1981 |
K811147 |
VITA-STAT |
VITA-STAT MODEL 9000-A |
06/30/1981 |
K152582 |
VOLCANO CORPORATION |
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box |
12/03/2015 |
K925899 |
WELCH ALLYN, INC. |
AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 |
05/21/1993 |
K811208 |
Y |
MODEL 1100 SPHYGMOMANOMETER |
05/21/1981 |
K011865 |
ZOLL MEDICAL CORP. |
ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION |
07/31/2001 |