FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K173381 |
Barco n.v. |
Nexxis OR |
02/22/2018 |
K170537 |
Barco n.v. |
Nexxis OR, Nexxis |
04/21/2017 |
K161880 |
Barco N.V. |
NIVR58-T kit |
03/14/2017 |
K133994 |
BARCO N.V. |
SIVR56-T KIT |
12/01/2014 |
K122167 |
BARCO NV |
NEXXIS OR |
04/22/2013 |
K083321 |
CURLVIEW IGT, LLC |
CARDIO-VIEW |
11/26/2008 |
K112645 |
EIZO GMBH |
RADIFORCE LARGE MONITOR SYSTEM |
09/22/2011 |
K162012 |
GE HEALTHCARE |
CARESCAPE Central Station V2 |
09/15/2016 |
K053356 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION |
04/19/2006 |
K133882 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) |
04/30/2014 |
K001112 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC |
06/14/2000 |
K992636 |
HEWLETT-PACKARD CO. |
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A |
08/31/1999 |
K212003 |
LivaNova Deutschland GmbH |
ESSENZ Patient Monitor |
11/10/2021 |
K131272 |
MEDUSA MEDICAL TECHNOLOGIES INC. |
SIREN EPCR SUITE |
01/03/2014 |
K942685 |
MORTARA INSTRUMENT, INC. |
ECG REVIEW STATION |
08/12/1997 |
K101474 |
PERKINS HEALTHCARE TECHNOLOGIES |
MD VISION SYSTEM |
07/02/2010 |
K100272 |
PHILIPS MEDICAL SYSTEMS |
INTELLIVUE CLINICAL INFORMATION PORTFOLIO |
04/14/2010 |
K151366 |
PHILIPS MEDICAL SYSTEMS |
Philips CS770 IntelliSpace Critical Care and Anesthesia |
10/30/2015 |
K151736 |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
Philips IntelliVue GuardianSoftware |
10/21/2015 |
K161767 |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
Philips IntelliVue GuardianSoftware |
01/27/2017 |
K180534 |
Philips Medizin Systeme Boeblingen GmbH |
Philips IntelliVue GuardianSoftware |
07/16/2018 |
K212208 |
Philips Medizin Systeme Boeblingen GmbH |
Philips IntelliVue GuardianSoftware (Rev. E.0X) |
09/30/2021 |
K111905 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 |
10/04/2011 |
K172969 |
Shenyang Torch-Bigtide Digital Technology Co., Ltd. |
Essence 55S Large Monitor System |
01/26/2018 |
K201162 |
Shenyang Torch-Bigtide Digital Technology Co., Ltd. |
Essence 55SP Large Monitor System |
08/27/2020 |
K013515 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
INFINITY EXPLORER |
01/10/2002 |
K170460 |
Sorin Group Deutschland GmbH |
Sorin Connect |
06/08/2017 |
K131816 |
SORIN GROUP DEUTSCHLAND GMBH |
SORIN CONNECT DATA MANAGEMENT SYSTEM |
07/23/2013 |
K962811 |
SPACELABS MEDICAL, INC. |
SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION |
06/24/1997 |
K110085 |
ST. JUDE MEDICAL |
VANTAGE VIEW SYSTEM |
01/26/2011 |
K073372 |
SYSTEMSONE |
ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) |
12/07/2007 |
K113214 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
TLINK DATA MANAGEMENT SYSTEM (DMS) |
02/07/2012 |
K173107 |
Vios Medical, Inc. |
Vios Central Station Monitor Software, Vios Central Server Software |
07/26/2018 |
K132488 |
ZOLL MEDICAL CORPORATION |
ZOLL CODE WRITER |
04/03/2014 |
K131919 |
ZOLL MEDICAL CORPORATION |
ZOLL EPCR IOS |
12/17/2013 |
K103473 |
ZOLL MEDICAL CORPORATION |
ZOLL RESCUENET EPCR MODEL RESCUENET EPCR |
05/13/2011 |