FDA Product Code
FDA Product Code DSK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1110
510(k) Clearances — 77 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30 | Endophys Technologies, LLC | 2023-11-03 | Traditional | PDF ↗ |
| K160945 | Endophys Blood Pressure Monitor | Endophys Holdings, LLC | 2016-09-26 | Traditional | PDF ↗ |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box | Volcano Corporation | 2015-12-03 | Special | PDF ↗ |
| K141615 | ENDOPHYS BLOOD PRESSURE MONITOR | Endophys, Inc. | 2015-01-07 | Traditional | PDF ↗ |
| K080670 | MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | Atcor Medical | 2008-04-23 | Special | PDF ↗ |
| K070795 | SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | Atcor Medical Pty, Ltd. | 2007-08-31 | Traditional | PDF ↗ |
| K033738 | MONITORING SYSTEM, MODEL ARGUS PB-2200 | Schiller AG | 2004-08-24 | Traditional | PDF ↗ |
| K021517 | ABP FOR WINDOWS | Rozinn Electronics, Inc. | 2002-07-24 | Traditional | PDF ↗ |
| K013943 | RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 | Radi Medical Systems AB | 2001-12-18 | Special | PDF ↗ |
| K011865 | ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION | Zoll Medical Corp | 2001-07-31 | Traditional | PDF ↗ |
| K003122 | SMARTFLOW, MODEL SFIP 2000 | Florence Medical , Ltd. | 2001-05-14 | Traditional | PDF ↗ |
| K002742 | SPHYGMOCOR MX MODEL SCOR-MX | Pwv Medical Pty, Lt. | 2001-05-01 | Traditional | PDF ↗ |
| K002067 | RADIANALYZER, MODEL 12710 | Radi Medical Systems AB | 2001-01-11 | Traditional | PDF ↗ |
| K983250 | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR | Magnetic Resonance Equipment Corp. | 1999-12-12 | Traditional | PDF ↗ |
| K951226 | VITALMAX 4000/MINIPACK 3100/3000 | Pace Tech, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K943457 | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | Datex Division Instrumentarium Corp. | 1994-07-27 | Traditional | PDF ↗ |
| K921388 | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE | Biochem International, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K925899 | AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 | Welch Allyn, Inc. | 1993-05-21 | Traditional | PDF ↗ |
| K914273 | A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR | A&D Engineering, Inc. | 1993-02-09 | Traditional | PDF ↗ |
| K912816 | PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE | S & W Medico Teknik | 1992-04-10 | Traditional | PDF ↗ |
| K912833 | CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY | Camino Laboratories, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K903900 | SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD. | Ppg Hellige B.V. | 1991-01-08 | Traditional | PDF ↗ |
| K901514 | XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS. | Ppg Industries, Inc. | 1990-11-16 | Traditional | PDF ↗ |
| K896535 | MEDILOG OPTIMA | Oxford Medilog, Inc. | 1990-01-18 | Traditional | PDF ↗ |
| K893232 | MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM | Camino Laboratories, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K884118 | TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA | S & W Medico Teknik | 1989-04-25 | Traditional | PDF ↗ |
| K884938 | VITAL SIGNS MONITOR | Tico Medical Instruments, Inc. | 1989-04-19 | Traditional | PDF ↗ |
| K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. | Spectramed, Inc. | 1989-01-25 | Traditional | PDF ↗ |
| K882085 | PROPAQ 104(TM) | Protocol Systems, Inc. | 1988-07-28 | Traditional | PDF ↗ |
| K882093 | CARDIOCAP(TM) CMO-104 MONITOR | Datex Division Instrumentarium Corp. | 1988-07-28 | Traditional | PDF ↗ |
| K880079 | TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420 | A&D Engineering, Inc. | 1988-03-31 | Traditional | PDF ↗ |
| K874338 | TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610 | A&D Engineering, Inc. | 1988-02-05 | Traditional | PDF ↗ |
| K874339 | TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620 | A&D Engineering, Inc. | 1987-12-18 | Traditional | PDF ↗ |
| K873765 | FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER | Nam Tai , Ltd. | 1987-10-09 | Traditional | PDF ↗ |
| K871720 | MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER | A&D Engineering, Inc. | 1987-07-29 | Traditional | PDF ↗ |
| K871718 | MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER | A&D Engineering, Inc. | 1987-06-24 | Traditional | PDF ↗ |
| K863042 | SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR | Siemens Medical Solutions USA, Inc. | 1987-01-14 | Traditional | PDF ↗ |
| K862200 | FORTEC MI-100, BLOOD PRESSURE METER | Fortec Electronic Corp./Nam Tai | 1986-11-18 | Traditional | PDF ↗ |
| K862455 | MODIFIED CARDIOCAP MONITOR | Datex Division Instrumentarium Corp. | 1986-09-24 | Traditional | PDF ↗ |
| K862647 | PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 | Ivy Biomedical Systems, Inc. | 1986-08-18 | Traditional | PDF ↗ |
| K860689 | SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE | Spacelabs, Inc. | 1986-07-30 | Traditional | PDF ↗ |
| K850879 | HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR | Mennen Medical, Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K844397 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 | Associated Mills, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K844396 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 | Associated Mills, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K832017 | LME BLOOD PRESSURE MONITOR | Litton Medical Electronics | 1983-10-31 | Traditional | PDF ↗ |
| K831481 | DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN | Eugene Scarberry | 1983-10-04 | Traditional | PDF ↗ |
| K822843 | HTS *1 | Global Office Automation System, Inc. | 1982-12-15 | Traditional | PDF ↗ |
| K822878 | MODEL 78553A PRESSURE PLUG-IN MODULE | Hewlett-Packard Co. | 1982-10-18 | Traditional | PDF ↗ |
| K811146 | VITA-STAT MODEL 8000-C | Vita-Stat | 1981-06-30 | Traditional | PDF ↗ |
| K811148 | VITA-STAT MODEL 9000-S | Viat-Stat | 1981-06-30 | Traditional | PDF ↗ |
| K811147 | VITA-STAT MODEL 9000-A | Vita-Stat | 1981-06-30 | Traditional | PDF ↗ |
| K811079 | SYPHGMOLOG | Cardiodyne General, Inc. | 1981-06-12 | Traditional | PDF ↗ |
| K811208 | MODEL 1100 SPHYGMOMANOMETER | Y | 1981-05-21 | Traditional | PDF ↗ |
| K810635 | ELECTRODE BLOOD PRESSURE MONITOR | Sears, Roebuck & Co. | 1981-05-08 | Traditional | PDF ↗ |
| K810172 | PRESSURE FUNCTION BLOCKS | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K810171 | PERIPHERAL PULSE FUNCTION BLOCKS | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K810178 | PATIENT MONITOR CM111, 112 | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K810179 | DUAL TRACE PATIENT MONITOR 116,118,120 | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K802925 | 6-415 FILTER, ELEMENT, 170-C | Lifecare Services, Inc. | 1980-12-19 | Traditional | PDF ↗ |
| K802600 | AMP PORTABLE PATIENT PRESSURE MONITOR | American Medical Products, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K801110 | PRESSURE MONITOR, MODEL 1131B | American Optical Corp. | 1980-05-20 | Traditional | PDF ↗ |
| K800360 | OUTPUT DIGITAL DISPLAY MODULE, MOD. 611 | Output, Inc. | 1980-02-29 | Traditional | PDF ↗ |
| K792077 | MODEL 1981 PRESSUROMETER DATA ANALYSIS | Del Mar Avionics | 1979-12-04 | Traditional | PDF ↗ |
| K791838 | HSH/H512 ADULT PHYSIOLOGICAL MONITORS | Medtel Pty. , Ltd. | 1979-10-01 | Traditional | PDF ↗ |
| K791839 | H59 CRITICAL CARE MONITOR | Medtel Pty. , Ltd. | 1979-10-01 | Traditional | PDF ↗ |
| K782073 | DINAMAP MODELS 1160 AND 1165 | Applied Medical Research | 1979-02-23 | Traditional | PDF ↗ |
| K790135 | MONITOR, PRESSURVEIL | Concept, Inc. | 1979-02-13 | Traditional | PDF ↗ |
| K781701 | BLOOD PRESSURE, DIGITAL MODEL #2153 | Sears, Roebuck & Co. | 1978-12-04 | Traditional | PDF ↗ |
| K781053 | DINAMAP MODEL 846 | Applied Medical Research | 1978-09-07 | Traditional | PDF ↗ |
| K781064 | DINAMAP MODEL 848 | Applied Medical Research | 1978-09-07 | Traditional | PDF ↗ |
| K780798 | GOULD-STATHAM SP1405 PRESSURE MONITOR | Gould, Inc. | 1978-06-13 | Traditional | PDF ↗ |
| K780356 | OUTPUT DIGITAL DISPLAY MODULE, MODEL 401 | Output, Inc. | 1978-05-31 | Traditional | PDF ↗ |
| K772334 | MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP | Telectronics, Inc. | 1978-02-21 | Traditional | PDF ↗ |
| K771981 | MINIMAP MODEL 810 | Applied Medical Research | 1978-01-24 | Traditional | PDF ↗ |
| K772234 | CARDIAC OUTPUT MODULE-78231C | Hewlett-Packard Co. | 1978-01-05 | Traditional | PDF ↗ |
| K771977 | CARDIAC OUTPUT COMPUTER MODEL 701 | Instrumentation Laboratory CO | 1978-01-03 | Traditional | PDF ↗ |
| K771772 | DINAMAP MODEL 825A | Applied Medical Research | 1977-10-04 | Traditional | PDF ↗ |
Product code DSK · Class II · Cardiovascular. Data: openFDA.