Computer, Blood-Pressure

FDA product code DSK · 75 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1110
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-10-04 – 2023-11-03

DSK 2023-11-03

Endophys Blood Pressure Monitor model BPM-30

Applicant Endophys Technologies, LLC

K number K231586

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DSK 2016-09-26

Endophys Blood Pressure Monitor

Applicant Endophys Holdings, LLC

K number K160945

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DSK 2008-04-23

MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

Applicant Atcor Medical

K number K080670

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DSK 2007-08-31

SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

Applicant Atcor Medical Pty, Ltd.

K number K070795

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DSK 2004-08-24

MONITORING SYSTEM, MODEL ARGUS PB-2200

Applicant Schiller AG

K number K033738

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DSK 2002-07-24

ABP FOR WINDOWS

Applicant Rozinn Electronics, Inc.

K number K021517

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DSK 2001-12-18

RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720

Applicant Radi Medical Systems AB

K number K013943

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DSK 2001-07-31

ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION

Applicant Zoll Medical Corp

K number K011865

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DSK 2001-05-14

SMARTFLOW, MODEL SFIP 2000

Applicant Florence Medical , Ltd.

K number K003122

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DSK 2001-05-01

SPHYGMOCOR MX MODEL SCOR-MX

Applicant Pwv Medical Pty, Lt.

K number K002742

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DSK 2001-01-11

RADIANALYZER, MODEL 12710

Applicant Radi Medical Systems AB

K number K002067

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DSK 1999-12-12

INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR

Applicant Magnetic Resonance Equipment Corp.

K number K983250

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DSK 1996-11-21

VITALMAX 4000/MINIPACK 3100/3000

Applicant Pace Tech, Inc.

K number K951226

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DSK 1994-07-27

AS/3 PRESSURE TEMPERATURE MODULE, M-PT

Applicant Datex Division Instrumentarium Corp.

K number K943457

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DSK 1993-05-26

BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE

Applicant Biochem International, Inc.

K number K921388

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DSK 1993-05-21

AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01

Applicant Welch Allyn, Inc.

K number K925899

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DSK 1993-02-09

A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR

Applicant A&D Engineering, Inc.

K number K914273

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DSK 1992-04-10

PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE

Applicant S & W Medico Teknik

K number K912816

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DSK 1991-09-23

CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY

Applicant Camino Laboratories, Inc.

K number K912833

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DSK 1991-01-08

SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.

Applicant Ppg Hellige B.V.

K number K903900

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DSK 1990-11-16

XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.

Applicant Ppg Industries, Inc.

K number K901514

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DSK 1990-01-18

MEDILOG OPTIMA

Applicant Oxford Medilog, Inc.

K number K896535

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DSK 1989-07-14

MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM

Applicant Camino Laboratories, Inc.

K number K893232

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DSK 1989-04-25

TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA

Applicant S & W Medico Teknik

K number K884118

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DSK 1989-04-19

VITAL SIGNS MONITOR

Applicant Tico Medical Instruments, Inc.

K number K884938

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DSK 1989-01-25

SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.

Applicant Spectramed, Inc.

K number K885235

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DSK 1988-07-28

CARDIOCAP(TM) CMO-104 MONITOR

Applicant Datex Division Instrumentarium Corp.

K number K882093

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DSK 1988-07-28

PROPAQ 104(TM)

Applicant Protocol Systems, Inc.

K number K882085

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DSK 1988-03-31

TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420

Applicant A&D Engineering, Inc.

K number K880079

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DSK 1988-02-05

TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610

Applicant A&D Engineering, Inc.

K number K874338

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DSK 1987-12-18

TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620

Applicant A&D Engineering, Inc.

K number K874339

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DSK 1987-10-09

FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER

Applicant Nam Tai , Ltd.

K number K873765

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DSK 1987-07-29

MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER

Applicant A&D Engineering, Inc.

K number K871720

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DSK 1987-06-24

MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER

Applicant A&D Engineering, Inc.

K number K871718

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DSK 1987-01-14

SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR

Applicant Siemens Medical Solutions USA, Inc.

K number K863042

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DSK 1986-11-18

FORTEC MI-100, BLOOD PRESSURE METER

Applicant Fortec Electronic Corp./Nam Tai

K number K862200

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DSK 1986-09-24

MODIFIED CARDIOCAP MONITOR

Applicant Datex Division Instrumentarium Corp.

K number K862455

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DSK 1986-08-18

PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403

Applicant Ivy Biomedical Systems, Inc.

K number K862647

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DSK 1986-07-30

SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE

Applicant Spacelabs, Inc.

K number K860689

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DSK 1985-04-25

HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR

Applicant Mennen Medical, Inc.

K number K850879

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DSK 1985-04-18

POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000

Applicant Associated Mills, Inc.

K number K844397

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DSK 1985-04-18

POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000

Applicant Associated Mills, Inc.

K number K844396

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DSK 1983-10-31

LME BLOOD PRESSURE MONITOR

Applicant Litton Medical Electronics

K number K832017

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DSK 1983-10-04

DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN

Applicant Eugene Scarberry

K number K831481

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DSK 1982-12-15

HTS *1

Applicant Global Office Automation System, Inc.

K number K822843

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DSK 1982-10-18

MODEL 78553A PRESSURE PLUG-IN MODULE

Applicant Hewlett-Packard Co.

K number K822878

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DSK 1981-06-30

VITA-STAT MODEL 9000-S

Applicant Viat-Stat

K number K811148

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DSK 1981-06-30

VITA-STAT MODEL 9000-A

Applicant Vita-Stat

K number K811147

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DSK 1981-06-30

VITA-STAT MODEL 8000-C

Applicant Vita-Stat

K number K811146

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DSK 1981-06-12

SYPHGMOLOG

Applicant Cardiodyne General, Inc.

K number K811079

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DSK 1981-05-21

MODEL 1100 SPHYGMOMANOMETER

Applicant Y

K number K811208

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DSK 1981-05-08

ELECTRODE BLOOD PRESSURE MONITOR

Applicant Sears, Roebuck & Co.

K number K810635

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DSK 1981-02-25

DUAL TRACE PATIENT MONITOR 116,118,120

Applicant Honeywell, Inc.

K number K810179

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DSK 1981-02-25

PATIENT MONITOR CM111, 112

Applicant Honeywell, Inc.

K number K810178

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DSK 1981-02-25

PRESSURE FUNCTION BLOCKS

Applicant Honeywell, Inc.

K number K810172

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DSK 1981-02-25

PERIPHERAL PULSE FUNCTION BLOCKS

Applicant Honeywell, Inc.

K number K810171

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DSK 1980-12-19

6-415 FILTER, ELEMENT, 170-C

Applicant Lifecare Services, Inc.

K number K802925

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DSK 1980-11-12

AMP PORTABLE PATIENT PRESSURE MONITOR

Applicant American Medical Products, Inc.

K number K802600

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DSK 1980-05-20

PRESSURE MONITOR, MODEL 1131B

Applicant American Optical Corp.

K number K801110

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DSK 1980-02-29

OUTPUT DIGITAL DISPLAY MODULE, MOD. 611

Applicant Output, Inc.

K number K800360

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DSK 1979-12-04

MODEL 1981 PRESSUROMETER DATA ANALYSIS

Applicant Del Mar Avionics

K number K792077

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DSK 1979-10-01

H59 CRITICAL CARE MONITOR

Applicant Medtel Pty. , Ltd.

K number K791839

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DSK 1979-10-01

HSH/H512 ADULT PHYSIOLOGICAL MONITORS

Applicant Medtel Pty. , Ltd.

K number K791838

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DSK 1979-02-23

DINAMAP MODELS 1160 AND 1165

Applicant Applied Medical Research

K number K782073

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DSK 1979-02-13

MONITOR, PRESSURVEIL

Applicant Concept, Inc.

K number K790135

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DSK 1978-12-04

BLOOD PRESSURE, DIGITAL MODEL #2153

Applicant Sears, Roebuck & Co.

K number K781701

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DSK 1978-09-07

DINAMAP MODEL 848

Applicant Applied Medical Research

K number K781064

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DSK 1978-09-07

DINAMAP MODEL 846

Applicant Applied Medical Research

K number K781053

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DSK 1978-06-13

GOULD-STATHAM SP1405 PRESSURE MONITOR

Applicant Gould, Inc.

K number K780798

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DSK 1978-05-31

OUTPUT DIGITAL DISPLAY MODULE, MODEL 401

Applicant Output, Inc.

K number K780356

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DSK 1978-02-21

MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP

Applicant Telectronics, Inc.

K number K772334

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DSK 1978-01-24

MINIMAP MODEL 810

Applicant Applied Medical Research

K number K771981

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DSK 1978-01-05

CARDIAC OUTPUT MODULE-78231C

Applicant Hewlett-Packard Co.

K number K772234

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DSK 1978-01-03

CARDIAC OUTPUT COMPUTER MODEL 701

Applicant Instrumentation Laboratory CO

K number K771977

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DSK 1977-10-04

DINAMAP MODEL 825A

Applicant Applied Medical Research

K number K771772

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