FDA 510(k) Applications for Medical Device Product Code "DSK"
(Computer, Blood-Pressure)

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


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