DSK · Computer, Blood-Pressure
Cardiovascular · 21 CFR 870.1110 · Class 2
Overview
| Product Code | DSK |
|---|---|
| Device Name | Computer, Blood-Pressure |
| Regulation | 21 CFR 870.1110 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 77)
Showing 20 most recent of 77 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30 | Endophys Technologies, LLC | Nov 3, 2023 | SESE |
| K160945 | Endophys Blood Pressure Monitor | Endophys Holdings, LLC | Sep 26, 2016 | SESE |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box | Volcano Corporation | Dec 3, 2015 | SESE |
| K141615 | ENDOPHYS BLOOD PRESSURE MONITOR | Endophys, Inc. | Jan 7, 2015 | SESE |
| K080670 | MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | Atcor Medical | Apr 23, 2008 | SESE |
| K070795 | SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | Atcor Medical Pty, Ltd. | Aug 31, 2007 | SESE |
| K033738 | MONITORING SYSTEM, MODEL ARGUS PB-2200 | Schiller AG | Aug 24, 2004 | SESE |
| K021517 | ABP FOR WINDOWS | Rozinn Electronics, Inc. | Jul 24, 2002 | SESE |
| K013943 | RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 | Radi Medical Systems AB | Dec 18, 2001 | SESE |
| K011865 | ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION | Zoll Medical Corp | Jul 31, 2001 | SESE |
| K003122 | SMARTFLOW, MODEL SFIP 2000 | Florence Medical , Ltd. | May 14, 2001 | SESE |
| K002742 | SPHYGMOCOR MX MODEL SCOR-MX | Pwv Medical Pty, Lt. | May 1, 2001 | SESE |
| K002067 | RADIANALYZER, MODEL 12710 | Radi Medical Systems AB | Jan 11, 2001 | SESE |
| K983250 | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR | Magnetic Resonance Equipment Corp. | Dec 12, 1999 | SESE |
| K951226 | VITALMAX 4000/MINIPACK 3100/3000 | Pace Tech, Inc. | Nov 21, 1996 | SESE |
| K943457 | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | Datex Division Instrumentarium Corp. | Jul 27, 1994 | SESE |
| K921388 | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE | Biochem International, Inc. | May 26, 1993 | SESE |
| K925899 | AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 | Welch Allyn, Inc. | May 21, 1993 | SESE |
| K914273 | A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR | A&D Engineering, Inc. | Feb 9, 1993 | SESE |
| K912816 | PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE | S & W Medico Teknik | Apr 10, 1992 | SESE |
Top Applicants
- A&D Engineering, Inc. — 6 clearances
- Applied Medical Research — 5 clearances
- Honeywell, Inc. — 4 clearances
- Datex Division Instrumentarium Corp. — 3 clearances
- Associated Mills, Inc. — 2 clearances
