Product code DSK
- Device name
- Computer, Blood-Pressure
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1110
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30 | Endophys Technologies, LLC | 2023-11-03 |
| K160945 | Endophys Blood Pressure Monitor | Endophys Holdings, LLC | 2016-09-26 |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box | Volcano Corporation | 2015-12-03 |
| K141615 | ENDOPHYS BLOOD PRESSURE MONITOR | Endophys, Inc. | 2015-01-07 |
| K080670 | MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | Atcor Medical | 2008-04-23 |
| K070795 | SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | Atcor Medical Pty, Ltd. | 2007-08-31 |
| K033738 | MONITORING SYSTEM, MODEL ARGUS PB-2200 | Schiller AG | 2004-08-24 |
| K021517 | ABP FOR WINDOWS | Rozinn Electronics, Inc. | 2002-07-24 |
| K013943 | RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 | Radi Medical Systems AB | 2001-12-18 |
| K011865 | ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION | Zoll Medical Corp | 2001-07-31 |
| K003122 | SMARTFLOW, MODEL SFIP 2000 | Florence Medical , Ltd. | 2001-05-14 |
| K002742 | SPHYGMOCOR MX MODEL SCOR-MX | Pwv Medical Pty, Lt. | 2001-05-01 |
| K002067 | RADIANALYZER, MODEL 12710 | Radi Medical Systems AB | 2001-01-11 |
| K983250 | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR | Magnetic Resonance Equipment Corp. | 1999-12-12 |
| K951226 | VITALMAX 4000/MINIPACK 3100/3000 | Pace Tech, Inc. | 1996-11-21 |
| K943457 | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | Datex Division Instrumentarium Corp. | 1994-07-27 |
| K921388 | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE | Biochem International, Inc. | 1993-05-26 |
| K925899 | AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 | Welch Allyn, Inc. | 1993-05-21 |
| K914273 | A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR | A&D Engineering, Inc. | 1993-02-09 |
| K912816 | PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE | S & W Medico Teknik | 1992-04-10 |
| K912833 | CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY | Camino Laboratories, Inc. | 1991-09-23 |
| K903900 | SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD. | Ppg Hellige B.V. | 1991-01-08 |
| K901514 | XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS. | Ppg Industries, Inc. | 1990-11-16 |
| K896535 | MEDILOG OPTIMA | Oxford Medilog, Inc. | 1990-01-18 |
| K893232 | MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM | Camino Laboratories, Inc. | 1989-07-14 |
| K884118 | TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA | S & W Medico Teknik | 1989-04-25 |
| K884938 | VITAL SIGNS MONITOR | Tico Medical Instruments, Inc. | 1989-04-19 |
| K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. | Spectramed, Inc. | 1989-01-25 |
| K882085 | PROPAQ 104(TM) | Protocol Systems, Inc. | 1988-07-28 |
| K882093 | CARDIOCAP(TM) CMO-104 MONITOR | Datex Division Instrumentarium Corp. | 1988-07-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729982852 | MDU5 PLUS | BOSTON SCIENTIFIC CORPORATION | 2021-11-29 |
| 08714729982869 | MDU5 PLUS | BOSTON SCIENTIFIC CORPORATION | 2021-11-29 |
| 08714729982845 | MDU5 PLUS | BOSTON SCIENTIFIC CORPORATION | 2021-11-29 |
| 08714729996538 | AVVIGO™ Guidance System | BOSTON SCIENTIFIC CORPORATION | 2020-08-17 |
| 08714729999966 | AVVIGO™ Guidance System | BOSTON SCIENTIFIC CORPORATION | 2020-08-17 |
| B510PM2000XLPRO1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000XLPLUS1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000XL1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000TM1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000M1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000APRO1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000A1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| 10884450385101 | Safedraw™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2019-08-08 |
| 10884450372538 | Safedraw™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2019-06-17 |
| 10884450326449 | Safedraw™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2019-02-28 |
| 10884450360603 | Safedraw™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2019-02-27 |
| 10884450384807 | Safedraw™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2018-11-07 |
| 10884450327057 | Safedraw™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2018-08-09 |
| 10884450326432 | Safedraw™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2018-03-29 |
| 10884450327668 | Safedraw™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2018-02-09 |
| 10884450326463 | Merit Medical® | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2018-01-26 |
| 10841522107788 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-10 |
| 10841522107771 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-10 |
| 20884838072248 | Spirometry Sensor | Philips Medizin Systeme Böblingen GmbH | 2017-01-20 |
| 10841522108792 | Spacelabs | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-11-15 |
| 10841522108778 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-11-15 |
| 10841522106415 | Ultraview SL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-07 |
| 10841522106422 | Ultraview SL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-07 |
| 20884838028726 | Genius 2 | Philips Medical Systems Hsg | 2016-10-05 |
| 19351315000017 | SphygmoCor | ATCOR MEDICAL PTY LTD | 2016-09-22 |