FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K080670 |
ATCOR MEDICAL |
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM |
04/23/2008 |
K070795 |
ATCOR MEDICAL PTY. LTD |
SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM |
08/31/2007 |
K160945 |
ENDOPHYS HOLDINGS, LLC |
Endophys Blood Pressure Monitor |
09/26/2016 |
K141615 |
ENDOPHYS, INC. |
ENDOPHYS BLOOD PRESSURE MONITOR |
01/07/2015 |
K003122 |
FLORENCE MEDICAL LTD. |
SMARTFLOW, MODEL SFIP 2000 |
05/14/2001 |
K983250 |
MAGNETIC RESONANCE EQUIPMENT CORP. |
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR |
12/12/1999 |
K951226 |
PACE TECH, INC. |
VITALMAX 4000/MINIPACK 3100/3000 |
11/21/1996 |
K002742 |
PWV MEDICAL PTY, LT. |
SPHYGMOCOR MX MODEL SCOR-MX |
05/01/2001 |
K002067 |
RADI MEDICAL SYSTEMS AB |
RADIANALYZER, MODEL 12710 |
01/11/2001 |
K013943 |
RADI MEDICAL SYSTEMS AB |
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 |
12/18/2001 |
K021517 |
ROZINN ELECTRONICS, INC. |
ABP FOR WINDOWS |
07/24/2002 |
K033738 |
SCHILLER AG |
MONITORING SYSTEM, MODEL ARGUS PB-2200 |
08/24/2004 |
K152582 |
VOLCANO CORPORATION |
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box |
12/03/2015 |
K011865 |
ZOLL MEDICAL CORP. |
ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION |
07/31/2001 |