DSK — Computer, Blood-Pressure Class II
FDA product code DSK covers "Computer, Blood-Pressure", a Class II medical device regulated under 21 CFR 870.1110. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DSK
- Device Class
- Class II
- Regulation Number
- 870.1110
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231586 | endophys technologies | Endophys Blood Pressure Monitor model BPM-30 | November 3, 2023 |
| K160945 | endophys holdings | Endophys Blood Pressure Monitor | September 26, 2016 |
| K152582 | volcano corporation | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box | December 3, 2015 |
| K141615 | endophys | ENDOPHYS BLOOD PRESSURE MONITOR | January 7, 2015 |
| K080670 | atcor medical | MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | April 23, 2008 |
| K070795 | atcor medical pty | SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | August 31, 2007 |
| K033738 | schiller | MONITORING SYSTEM, MODEL ARGUS PB-2200 | August 24, 2004 |
| K021517 | rozinn electronics | ABP FOR WINDOWS | July 24, 2002 |
| K013943 | radi medical systems | RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 | December 18, 2001 |
| K011865 | zoll medical | ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION | July 31, 2001 |
| K003122 | florence medical | SMARTFLOW, MODEL SFIP 2000 | May 14, 2001 |
| K002742 | pwv medical pty, lt | SPHYGMOCOR MX MODEL SCOR-MX | May 1, 2001 |
| K002067 | radi medical systems | RADIANALYZER, MODEL 12710 | January 11, 2001 |
| K983250 | magnetic resonance equipment | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR | December 12, 1999 |
| K951226 | pace tech | VITALMAX 4000/MINIPACK 3100/3000 | November 21, 1996 |
| K943457 | datex division instrumentarium | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | July 27, 1994 |
| K921388 | biochem international | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE | May 26, 1993 |
| K925899 | welch allyn | AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 | May 21, 1993 |
| K914273 | a and d engineering | A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR | February 9, 1993 |
| K912816 | s and w medico teknik | PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE | April 10, 1992 |