FDA 510(k) Applications Submitted by PHILIPS MEDICAL SYSTEMS

FDA 510(k) Number Submission Date Device Name Applicant
K022920 09/04/2002 M2376A DEVICELINK SYSTEM PHILIPS MEDICAL SYSTEMS
K131590 05/31/2013 INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE PHILIPS MEDICAL SYSTEMS
K081983 07/11/2008 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 PHILIPS MEDICAL SYSTEMS
K093177 10/08/2009 INTELLIBRIDGE SYSTEM PHILIPS MEDICAL SYSTEMS
K051134 05/03/2005 HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A PHILIPS MEDICAL SYSTEMS
K020531 02/19/2002 PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B PHILIPS MEDICAL SYSTEMS
K021251 04/19/2002 ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. PHILIPS MEDICAL SYSTEMS
K021300 04/24/2002 MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B PHILIPS MEDICAL SYSTEMS
K021422 05/03/2002 PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02 PHILIPS MEDICAL SYSTEMS
K021778 05/30/2002 PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B PHILIPS MEDICAL SYSTEMS
K050742 03/22/2005 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00 PHILIPS MEDICAL SYSTEMS
K030973 03/28/2003 PICOSAT II SPO2 PULSE OXIMETRY MODULE PHILIPS MEDICAL SYSTEMS
K062271 08/07/2006 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) PHILIPS MEDICAL SYSTEMS
K023674 11/01/2002 PHILIPS DRUG CALCULATOR SOFTWARE PHILIPS MEDICAL SYSTEMS
K023698 11/04/2002 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O PHILIPS MEDICAL SYSTEMS
K033513 11/06/2003 EASI ECG ALGORITHM PHILIPS MEDICAL SYSTEMS
K023871 11/20/2002 M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY PHILIPS MEDICAL SYSTEMS
K070260 01/26/2007 STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0 PHILIPS MEDICAL SYSTEMS
K021347 04/29/2002 MODIFICATION TO M2376A DEVICELINK SYSTEM PHILIPS MEDICAL SYSTEMS
K063375 11/08/2006 HEARTSTART MRX, MODELS M3535A OR M3536A PHILIPS MEDICAL SYSTEMS
K102974 10/06/2010 INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 PHILIPS MEDICAL SYSTEMS
K163649 12/23/2016 SureSigns VS3; SureSigns VS4 Philips Medical Systems
K133961 12/24/2013 SURESIGNS VS3, SURESIGNS VS4 PHILIPS MEDICAL SYSTEMS
K041401 05/26/2004 MODIFICATION TO M2376A DEVICELINK SYSTEM PHILIPS MEDICAL SYSTEMS
K033680 11/24/2003 M2376A PHILIPS DEVICE LINK SYSTEM PHILIPS MEDICAL SYSTEMS
K041674 06/21/2004 THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT PHILIPS MEDICAL SYSTEMS
K023749 11/08/2002 THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B) PHILIPS MEDICAL SYSTEMS
K133659 11/27/2013 HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING PHILIPS MEDICAL SYSTEMS
K063559 11/27/2006 ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 PHILIPS MEDICAL SYSTEMS
K030939 03/25/2003 PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE PHILIPS MEDICAL SYSTEMS
K111114 04/21/2011 SURESIGNS VS2 VITAL SIGNS MONITOR PHILIPS MEDICAL SYSTEMS
K151366 05/21/2015 Philips CS770 IntelliSpace Critical Care and Anesthesia PHILIPS MEDICAL SYSTEMS
K090483 02/25/2009 SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS PHILIPS MEDICAL SYSTEMS
K072812 10/01/2007 PHILIPS HEARTSTART SMARTPADS III PHILIPS MEDICAL SYSTEMS
K110572 03/01/2011 MAMMODIAGNOST DR PHILIPS MEDICAL SYSTEMS
K123492 11/13/2012 DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) PHILIPS MEDICAL SYSTEMS
K101521 06/02/2010 ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O PHILIPS MEDICAL SYSTEMS
K020055 01/08/2002 PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION PHILIPS MEDICAL SYSTEMS
K031815 06/12/2003 INTERA-SENSATION FAMILY PHILIPS MEDICAL SYSTEMS
K062650 09/07/2006 EP NAVIGATOR SOFTWARE PHILIPS MEDICAL SYSTEMS
K023440 10/15/2002 PHILIPS DIGITAL IMAGING OPTION RELEASE 1 PHILIPS MEDICAL SYSTEMS
K023441 10/15/2002 PHILIPS MULTIDIAGNOST ELEVA PHILIPS MEDICAL SYSTEMS
K032096 07/08/2003 PHILIPS VIEWFORUM 2003 PHILIPS MEDICAL SYSTEMS
K130153 01/22/2013 HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST PHILIPS MEDICAL SYSTEMS
K120132 01/17/2012 SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR PHILIPS MEDICAL SYSTEMS
K080495 02/22/2008 SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3 PHILIPS MEDICAL SYSTEMS
K110803 03/23/2011 SURESIGNS VSI VITAL SIGNS MONITOR PHILIPS MEDICAL SYSTEMS
K160951 04/05/2016 Philips Efficia CMS200 Central Monitoring System PHILIPS MEDICAL SYSTEMS
K131032 04/12/2013 PHILIPS SURESIGNS CENTRAL PHILIPS MEDICAL SYSTEMS
K151812 07/02/2015 PATIENT MONITORS VARIOUS MODELS PHILIPS MEDICAL SYSTEMS
K152363 08/20/2015 Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M PHILIPS MEDICAL SYSTEMS
K112652 09/12/2011 SURESIGNS VS2+ -SURESIGNS VSI PHILIPS MEDICAL SYSTEMS
K123900 12/18/2012 SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 PHILIPS MEDICAL SYSTEMS
K052707 09/29/2005 M3046B COMPACT PORTABLE PATIENT MONITORS PHILIPS MEDICAL SYSTEMS
K130684 03/13/2013 PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR PHILIPS MEDICAL SYSTEMS
K020456 02/11/2002 EASI 12 LEAD ALGORITHM PHILIPS MEDICAL SYSTEMS
K110825 03/23/2011 PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES PHILIPS MEDICAL SYSTEMS
K080999 04/08/2008 PAGEWRITER CARDIOGRAPH PHILIPS MEDICAL SYSTEMS
K091176 04/22/2009 PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 PHILIPS MEDICAL SYSTEMS
K113144 10/25/2011 PAGEWRITER TC 20, 30, 50, 70 PHILIPS MEDICAL SYSTEMS
K073376 12/03/2007 PHILIPS ECG ALGORITHM PHILIPS MEDICAL SYSTEMS
K101067 04/16/2010 SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068 PHILIPS MEDICAL SYSTEMS
K030417 02/10/2003 DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES PHILIPS MEDICAL SYSTEMS
K031187 04/15/2003 HEARTSTART MRX, MODEL M3535A PHILIPS MEDICAL SYSTEMS
K110287 01/31/2011 PHILIPS ECG LEADWIRE SET PHILIPS MEDICAL SYSTEMS
K120815 03/19/2012 INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE PHILIPS MEDICAL SYSTEMS
K071885 07/09/2007 ANTIMICROBIAL AND SINGLE-PATIENT CUFFS PHILIPS MEDICAL SYSTEMS
K062455 08/23/2006 PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL PHILIPS MEDICAL SYSTEMS
K062605 09/05/2006 PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T PHILIPS MEDICAL SYSTEMS
K021453 05/06/2002 HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A PHILIPS MEDICAL SYSTEMS
K071564 06/07/2007 MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 PHILIPS MEDICAL SYSTEMS
K031422 05/06/2003 PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291 PHILIPS MEDICAL SYSTEMS
K061707 06/16/2006 HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS PHILIPS MEDICAL SYSTEMS
K032103 07/08/2003 PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A PHILIPS MEDICAL SYSTEMS
K052049 07/29/2005 PHILIPS 12-LEAD ALGORITHM PHILIPS MEDICAL SYSTEMS
K014191 12/21/2001 M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 PHILIPS MEDICAL SYSTEMS
K132524 08/12/2013 CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION PHILIPS MEDICAL SYSTEMS
K133603 11/25/2013 PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION PHILIPS MEDICAL SYSTEMS
K020715 03/05/2002 PHILIPS M5066A AND M5068A PHILIPS MEDICAL SYSTEMS
K111693 06/16/2011 PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR PHILIPS MEDICAL SYSTEMS
K051632 06/20/2005 PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A PHILIPS MEDICAL SYSTEMS
K013425 10/16/2001 HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A PHILIPS MEDICAL SYSTEMS
K014157 12/19/2001 HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A PHILIPS MEDICAL SYSTEMS
K070588 03/01/2007 PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) PHILIPS MEDICAL SYSTEMS
K052961 10/21/2005 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN PHILIPS MEDICAL SYSTEMS
K033444 10/29/2003 PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER PHILIPS MEDICAL SYSTEMS
K100272 01/29/2010 INTELLIVUE CLINICAL INFORMATION PORTFOLIO PHILIPS MEDICAL SYSTEMS
K083413 11/18/2008 COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM PHILIPS MEDICAL SYSTEMS
K040904 04/07/2004 PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A PHILIPS MEDICAL SYSTEMS
K161164 04/25/2016 CareEvent inclusive of the CareEvent Mobile Application accessory PHILIPS MEDICAL SYSTEMS
K180017 01/02/2018 MX40 Release C.01 Philips Medical Systems
K132068 07/03/2013 PHILIPS DXL 12/16-LEAD ECG ALGORITHM PHILIPS MEDICAL SYSTEMS
K172226 07/25/2017 MX40 Release B.07 Philips Medical Systems
K102495 08/31/2010 M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 PHILIPS MEDICAL SYSTEMS
K142935 10/09/2014 CareEvent PHILIPS MEDICAL SYSTEMS
K113125 10/24/2011 INTELLIVUE MX40 PATIENT MONITOR PHILIPS MEDICAL SYSTEMS
K143057 10/24/2014 M3290B Philips IntelliVue Information Center iX PHILIPS MEDICAL SYSTEMS
K163584 12/20/2016 M3290B Philips IntelliVue Information Center iX Philips Medical Systems
K153702 12/23/2015 M3290B Philips IntelliVue Information Center iX PHILIPS MEDICAL SYSTEMS
K050004 01/02/2005 PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 PHILIPS MEDICAL SYSTEMS
K080461 02/20/2008 STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 PHILIPS MEDICAL SYSTEMS


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