FDA 510(k) Applications for Medical Device Product Code "MSX"
(System,Network And Communication,Physiological Monitors)

FDA 510(k) Number Applicant Device Name Decision Date
K211949 AirStrip Technologies, Inc. AirStrip ONE Web Client with Alarm Communication Management (ACM) 12/09/2021
K160862 AirStrip Technologies, Inc. AirStrip RPM 09/19/2016
K121712 AIRSTRIP TECHNOLOGIES, INC. AIRSTRIP RPM FOR LIFENET CONSULT 11/20/2012
K210160 AlertWatch, Inc. AlertWatch:AC 09/10/2021
K112047 AMCOM SOFTWARE,INC. AMCOM COMMTECH MESSENGER 09/13/2011
K111215 ASCOM (SWEDEN) AB ASCOM MOBILE MONITORING GATEWAY (MMG) 07/05/2011
K103634 ASCOM (US), INC. ASCOM CLINICALCONNEX CARDIOMAX 02/23/2011
K180566 Ascom Sweden AB Unite Connect for Clinical Systems 04/03/2018
K180430 ASCOM UMS srl unipersonale Digistat Smart Central 11/23/2018
K173203 Athena GTX Athena GTX Device Management Suite (ADMS) Software 03/14/2018
K213863 Biofourmis Singapore Pte. Ltd Everion+ System 02/23/2023
K193421 BoxView, LLC Smart Alarm Interface 10/30/2020
K061428 CARD GUARD SCIENTIFIC SURVIVAL, LTD. PMP4 APPLICATION 10/16/2006
K061932 CARDIOPULMONARY CORP. BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE 09/14/2006
K020018 CARDIOPULMONARY CORP. MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE 02/21/2002
K051283 CARDIOPULMONARY CORP. MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE 06/23/2005
K151672 CERNER CORPORATION Cerner CareAware Event Management 12/21/2015
K112650 CONNEXALL USA, INC. CONNEXALL SUITE OF SOFTWARE PRODUCTS 02/01/2012
K193043 Critical Alert Critical Alert CommonPath Enterprise 05/11/2020
K982342 CRITIKON COMPANY,LLC DINAMAP MPS SELECT PORTABLE MONITOR 08/14/1998
K210133 Current Health Current Health Monitoring System Gen 2 (G2) 09/03/2021
K231506 Current Health Ltd Current Health System 08/24/2023
K190073 Current Health Ltd Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub 03/27/2019
K222550 Current Health Ltd. Current Health System 11/01/2022
K191272 Current Health Ltd. Wearable Device, Wearable Package 07/12/2019
K992848 DATA CRITICAL CORP. ALARMVIEW SYSTEM 11/19/1999
K010912 DATA CRITICAL CORP. ALARMVIEW WIRELESS DATA NETWORK SYSTEM 04/05/2001
K973527 DATA CRITICAL CORP. CARDIO-PAGER SYSTEM 03/31/1998
K003998 DATA CRITICAL CORP. FLEXVIEW CLINICAL MONITORING SYSTEM 03/07/2001
K012005 DATA CRITICAL CORP. MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM 07/24/2001
K013156 DATA CRITICAL CORP. MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM 10/19/2001
K011999 DATA CRITICAL CORP. MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM 07/24/2001
K990378 DATA CRITICAL CORP. STATVIEW SYSTEM 09/20/1999
K962473 DATA CRITICAL CORPORATION (VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH 11/06/1997
K974101 DATEX-ENGSTROM, INC. DATEX-ENGSTROM NETWORK 02/06/1998
K033281 DATEX-OHMEDA DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE 11/26/2003
K033078 DATEX-OHMEDA DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE 10/29/2003
K012531 DATEX-OHMEDA DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX 11/02/2001
K013246 DATEX-OHMEDA DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 12/11/2001
K022507 DATEX-OHMEDA DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02 08/23/2002
K013387 DATEX-OHMEDA DATEX-OHMEDA S/5 WEB VIEWER 01/08/2002
K023497 DATEX-OHMEDA DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE 11/04/2002
K042771 DATEX-OHMEDA GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 10/15/2004
K000647 DATEX-OHMEDA, INC. DATEX-OHMEDA NETWORK AND CENTRAL 07/13/2000
K141756 Draeger Medical Systems, Inc. INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION 12/12/2014
K203579 Draeger Medical Systems, Inc. Infinity Gateway Suite 06/07/2022
K040945 Draeger Medical Systems, Inc. MODIFICATION TO INFINITY EXPLORER 05/12/2004
K060254 Draeger Medical Systems, Inc. MODIFICATION TO INFINITY EXPLORER 04/04/2006
K151006 EARLYSENSE LTD. EarlySense Central Display Station (CDS) 08/31/2015
K121885 EARLYSENSE LTD. EARLYSENSE CENTRAL DISPLAY SYSTEM 09/10/2012
K100376 EARLYSENSE LTD. EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 08/06/2010
K110521 EARLYSENSE LTD. EVERON CENTRAL DISPLAY STATION (CDS) 04/19/2011
K130339 EXTENSION , INC CLINICAL ALERT NOTIFICATION 07/11/2013
K052972 GE HEALTHCARE DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 12/29/2005
K051634 GE HEALTHCARE DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION 07/19/2005
K070421 GE HEALTHCARE DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 03/13/2007
K052975 GE HEALTHCARE DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE 01/20/2006
K061994 GE HEALTHCARE WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE 08/11/2006
K032346 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES UNITY NETWORK IS PATIENT VIEWER 08/05/2003
K032582 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES UNITY NETWORK PATIENT DATA SERVER 09/17/2003
K994430 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM 03/28/2000
K020524 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN PATIENTNET MONITORING SYSTEM 03/20/2002
K020661 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN UNITY IS PATIENT VIEWER 05/24/2002
K974567 HEWLETT-PACKARD CO. HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER 01/20/1998
K130707 ISIRONA, LLC ISIRONA MAGELLAN 11/20/2013
K971569 JOHNSON & JOHNSON MEDICAL, INC. DINAMAP MPS PORTABLE MONITOR 09/19/1997
K971868 MARQUETTE ELECTRONICS, INC. IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM 11/13/1997
K971683 MARQUETTE ELECTRONICS, INC. WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET 10/22/1997
K071047 MASIMO CORPORATION MASIMO PATIENT SAFETY NET 06/08/2007
K052854 MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. LIFENET EXCHANGE SYSTEM 01/20/2006
K112282 MVISUM, INC. M VISUM ALERT ALARM MANAGEMENT SYSTEM 11/04/2011
K223567 Nihon Kohden Corporation CNS-2101 Central Monitor 07/31/2023
K973318 ORTIVUS US, INC. MOBIMED SYSTEM, (PEGASUS AND POLARIS) 02/19/1998
K142935 PHILIPS MEDICAL SYSTEMS CareEvent 01/15/2015
K161164 PHILIPS MEDICAL SYSTEMS CareEvent inclusive of the CareEvent Mobile Application accessory 06/24/2016
K102974 PHILIPS MEDICAL SYSTEMS INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 01/04/2011
K143057 PHILIPS MEDICAL SYSTEMS M3290B Philips IntelliVue Information Center iX 12/03/2014
K091176 PHILIPS MEDICAL SYSTEMS PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 11/13/2009
K071391 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 09/07/2007
K182637 Philips Medizin Systeme Boeblingen GmbH Philips IntelliVue XDS Software 04/26/2019
K042845 PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS 11/12/2004
K093925 PHYSIO-CONTROL, INC. LIFENET SYSTEM 01/12/2010
K102757 PHYSIO-CONTROL, INC. LIFENET SYSTEM 11/05/2010
K162607 Shenzhen Mindray Bio-Medical Electronics Co., Ltd BeneVision Central Monitoring System 04/20/2017
K220058 Shenzhen Mindray Bio-Medical Electronics Co., LTD BeneVision Central Monitoring System 06/01/2022
K150632 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Hypervisor IX Monitoring System 07/06/2015
K080192 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) 04/03/2008
K183238 Shenzhen Mindray Bio-medical Electronics Co., LTD. BeneVision Central Monitoring System 03/13/2019
K193391 Shenzhen Mindray Bio-medical Electronics Co., LTD. BeneVision Central Monitoring System 05/21/2020
K132036 SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) 07/01/2014
K030615 SIEMENS MEDICAL SOLUTIONS USA, INC. INFINITY EXPLORER 03/21/2003
K182543 snap40 Ltd Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package 11/14/2018
K062278 SPACELABS MEDICAL INC. SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 09/19/2006
K992749 SPACELABS MEDICAL, INC. ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841 01/14/2000
K192952 Spire, Inc. d/b/a Spire Health Spire Health Remote Patient Monitoring System 06/05/2020
K202497 Taiwan Aulisa Medical Devices Technologies, Inc. Aulisa Multiple Patient Digital Vital Sign Monitoring System 10/30/2020
K973640 TRINCORE SYSTEMS, INC. TS2000 MEDICAL DEVICE MONITOR 03/12/1998
K140852 VECTRACOR, INC VECTRAPLEX CMS 01/30/2015
K972880 VIDCO, INC. MDP2000 MEDICAL DATA PROCESSOR 10/22/1997
K001972 VISICU, INC. ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK 10/27/2000
K153156 VISICU, INC. eCareManager 4.0.1 09/30/2016
K171322 Visicu, Inc. eCareManager 4.1 08/03/2017
K211046 Visicu, Inc. eCareManager 4.5 06/03/2022
K012171 VISICU, INC. MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS 07/24/2001
K070204 WELCH ALLYN PROTOCOL, INC. LINK TO ACUITY CLINICIAN NOTIFIER 03/23/2007
K121865 ZOLL MEDICAL CORPORATION ZOLL RESCUENET 12-LEAD 11/20/2012
K111296 ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS ZOLL RESCUENETLINK 10/27/2011
K212622 Zyter, Inc. Zyter RPM 02/11/2022


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