Product Code: MSX FDA class 2 21 CFR 870.2300

System, Network And Communication, Physiological Monitors

Cardiovascular

A Physiological Monitor Network and Communication System is a device infrastructure that enables the transmission, reception, and management of patient physiological data between bedside monitors and central stations or other networked systems in clinical settings. It is classified as FDA Class 2, requiring 510(k) clearance, with product code MSX under 21 CFR 870.2300 in the Cardiovascular specialty, and is designated as life-sustaining due to its role in critical patient monitoring. The device is not an implant.

View on FDA

510(k)s

114

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: MSX
Device Class: FDA class 2
Regulation Number: 870.2300
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 114 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242750	Central Station	Jun 05, 2025	Substantially Equivalent	Nihon Kohden Digital Health Solutions, LLC
K242842	ANNE View, Central Hub	Jan 08, 2025	Substantially Equivalent	Sibel Health Inc.
K241397	Hinscope	Nov 14, 2024	Substantially Equivalent	Hinlab SAS
K233834	Infinity Gateway Suite	Jul 12, 2024	Substantially Equivalent	Draeger Medical Systems, Inc.
K233418	Biofourmis Everion+ (G2)	May 09, 2024	Substantially Equivalent	Biofourmis Singapore Pte. Ltd.
K232548	Corsano CardioWatch 287-2 System	Mar 22, 2024	Substantially Equivalent	Corsano Health B.V.
K231506	Current Health System	Aug 24, 2023	Substantially Equivalent	Current Health Ltd
K223567	CNS-2101 Central Monitor	Jul 31, 2023	Substantially Equivalent	Nihon Kohden Corporation
K213863	Everion+ System	Feb 23, 2023	Substantially Equivalent	Biofourmis Singapore Pte. Ltd
K222550	Current Health System	Nov 01, 2022	Substantially Equivalent	Current Health Ltd.
K203579	Infinity Gateway Suite	Jun 07, 2022	Substantially Equivalent	Draeger Medical Systems, Inc.
K211046	eCareManager 4.5	Jun 03, 2022	Substantially Equivalent	Visicu, Inc.
K220058	BeneVision Central Monitoring System	Jun 01, 2022	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., LTD
K212622	Zyter RPM	Feb 11, 2022	Substantially Equivalent	Zyter, Inc.
K211949	AirStrip ONE Web Client with Alarm Communication Management (ACM)	Dec 09, 2021	Substantially Equivalent	AirStrip Technologies, Inc.
K210160	AlertWatch:AC	Sep 10, 2021	Substantially Equivalent	AlertWatch, Inc.
K210133	Current Health Monitoring System Gen 2 (G2)	Sep 03, 2021	Substantially Equivalent	Current Health
K202497	Aulisa Multiple Patient Digital Vital Sign Monitoring System	Oct 30, 2020	Substantially Equivalent	Taiwan Aulisa Medical Devices Technologies, Inc.
K193421	Smart Alarm Interface	Oct 30, 2020	Substantially Equivalent	BoxView, LLC
K192952	Spire Health Remote Patient Monitoring System	Jun 05, 2020	Substantially Equivalent	Spire, Inc. d/b/a Spire Health
K193391	BeneVision Central Monitoring System	May 21, 2020	Substantially Equivalent	Shenzhen Mindray Bio-medical Electronics Co., LTD.
K193043	Critical Alert CommonPath Enterprise	May 11, 2020	Substantially Equivalent	Critical Alert
K191272	Wearable Device, Wearable Package	Jul 12, 2019	Substantially Equivalent	Current Health Ltd.
K182637	Philips IntelliVue XDS Software	Apr 26, 2019	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K190073	Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub	Mar 27, 2019	Substantially Equivalent	Current Health Ltd
K183238	BeneVision Central Monitoring System	Mar 13, 2019	Substantially Equivalent	Shenzhen Mindray Bio-medical Electronics Co., LTD.
K180430	Digistat Smart Central	Nov 23, 2018	Substantially Equivalent	ASCOM UMS srl unipersonale
K182543	Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package	Nov 14, 2018	Substantially Equivalent	snap40 Ltd
K180566	Unite Connect for Clinical Systems	Apr 03, 2018	Substantially Equivalent	Ascom Sweden AB
K173203	Athena GTX Device Management Suite (ADMS) Software	Mar 14, 2018	Substantially Equivalent	Athena GTX
K171322	eCareManager 4.1	Aug 03, 2017	Substantially Equivalent	Visicu, Inc.
K162607	BeneVision Central Monitoring System	Apr 20, 2017	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K153156	eCareManager 4.0.1	Sep 30, 2016	Substantially Equivalent	VISICU, INC.
K160862	AirStrip RPM	Sep 19, 2016	Substantially Equivalent	AirStrip Technologies, Inc.
K161164	CareEvent inclusive of the CareEvent Mobile Application accessory	Jun 24, 2016	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K151672	Cerner CareAware Event Management	Dec 21, 2015	Substantially Equivalent	CERNER CORPORATION
K151006	EarlySense Central Display Station (CDS)	Aug 31, 2015	Substantially Equivalent	EARLYSENSE LTD.
K150632	Hypervisor IX Monitoring System	Jul 06, 2015	Substantially Equivalent	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K140852	VECTRAPLEX CMS	Jan 30, 2015	Substantially Equivalent	VECTRACOR, INC
K142935	CareEvent	Jan 15, 2015	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K141756	INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION	Dec 12, 2014	Substantially Equivalent	Draeger Medical Systems, Inc.
K143057	M3290B Philips IntelliVue Information Center iX	Dec 03, 2014	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K132036	HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)	Jul 01, 2014	Substantially Equivalent	SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
K130707	ISIRONA MAGELLAN	Nov 20, 2013	Substantially Equivalent	ISIRONA, LLC
K130339	CLINICAL ALERT NOTIFICATION	Jul 11, 2013	Substantially Equivalent	EXTENSION , INC
K121865	ZOLL RESCUENET 12-LEAD	Nov 20, 2012	Substantially Equivalent	ZOLL MEDICAL CORPORATION
K121712	AIRSTRIP RPM FOR LIFENET CONSULT	Nov 20, 2012	Substantially Equivalent	AIRSTRIP TECHNOLOGIES, INC.
K121885	EARLYSENSE CENTRAL DISPLAY SYSTEM	Sep 10, 2012	Substantially Equivalent	EARLYSENSE LTD.
K112650	CONNEXALL SUITE OF SOFTWARE PRODUCTS	Feb 01, 2012	Substantially Equivalent	CONNEXALL USA, INC.
K112282	M VISUM ALERT ALARM MANAGEMENT SYSTEM	Nov 04, 2011	Substantially Equivalent	MVISUM, INC.
K111296	ZOLL RESCUENETLINK	Oct 27, 2011	Substantially Equivalent	ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
K112047	AMCOM COMMTECH MESSENGER	Sep 13, 2011	Substantially Equivalent	AMCOM SOFTWARE,INC.
K111215	ASCOM MOBILE MONITORING GATEWAY (MMG)	Jul 05, 2011	Substantially Equivalent	ASCOM (SWEDEN) AB
K110521	EVERON CENTRAL DISPLAY STATION (CDS)	Apr 19, 2011	Substantially Equivalent	EARLYSENSE LTD.
K103634	ASCOM CLINICALCONNEX CARDIOMAX	Feb 23, 2011	Substantially Equivalent	ASCOM (US), INC.
K102974	INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00	Jan 04, 2011	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K102757	LIFENET SYSTEM	Nov 05, 2010	Substantially Equivalent	PHYSIO-CONTROL, INC.
K100376	EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0	Aug 06, 2010	Substantially Equivalent	EARLYSENSE LTD.
K093925	LIFENET SYSTEM	Jan 12, 2010	Substantially Equivalent	PHYSIO-CONTROL, INC.
K091176	PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441	Nov 13, 2009	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K080192	HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)	Apr 03, 2008	Substantially Equivalent	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K071391	PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521	Sep 07, 2007	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K071047	MASIMO PATIENT SAFETY NET	Jun 08, 2007	Substantially Equivalent	MASIMO CORPORATION
K070204	LINK TO ACUITY CLINICIAN NOTIFIER	Mar 23, 2007	Substantially Equivalent	WELCH ALLYN PROTOCOL, INC.
K070421	DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02	Mar 13, 2007	Substantially Equivalent	GE HEALTHCARE
K061428	PMP4 APPLICATION	Oct 16, 2006	Substantially Equivalent	CARD GUARD SCIENTIFIC SURVIVAL, LTD.
K062278	SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847	Sep 19, 2006	Substantially Equivalent	SPACELABS MEDICAL INC.
K061932	BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE	Sep 14, 2006	Substantially Equivalent	CARDIOPULMONARY CORP.
K061994	WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE	Aug 11, 2006	Substantially Equivalent	GE HEALTHCARE
K060254	MODIFICATION TO INFINITY EXPLORER	Apr 04, 2006	Substantially Equivalent	Draeger Medical Systems, Inc.
K052975	DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE	Jan 20, 2006	Substantially Equivalent	GE HEALTHCARE
K052854	LIFENET EXCHANGE SYSTEM	Jan 20, 2006	Substantially Equivalent	MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
K052972	DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3	Dec 29, 2005	Substantially Equivalent	GE HEALTHCARE
K051634	DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION	Jul 19, 2005	Substantially Equivalent	GE HEALTHCARE
K051283	MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE	Jun 23, 2005	Substantially Equivalent	CARDIOPULMONARY CORP.
K042845	THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS	Nov 12, 2004	Substantially Equivalent	PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH
K042771	GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3	Oct 15, 2004	Substantially Equivalent	DATEX-OHMEDA
K040945	MODIFICATION TO INFINITY EXPLORER	May 12, 2004	Substantially Equivalent	Draeger Medical Systems, Inc.
K033281	DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE	Nov 26, 2003	Substantially Equivalent	DATEX-OHMEDA
K033078	DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE	Oct 29, 2003	Substantially Equivalent	DATEX-OHMEDA
K032582	UNITY NETWORK PATIENT DATA SERVER	Sep 17, 2003	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032346	UNITY NETWORK IS PATIENT VIEWER	Aug 05, 2003	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K030615	INFINITY EXPLORER	Mar 21, 2003	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K023497	DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE	Nov 04, 2002	Substantially Equivalent	DATEX-OHMEDA
K022507	DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02	Aug 23, 2002	Substantially Equivalent	DATEX-OHMEDA
K020661	UNITY IS PATIENT VIEWER	May 24, 2002	Substantially Equivalent	GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K020524	PATIENTNET MONITORING SYSTEM	Mar 20, 2002	Substantially Equivalent	GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K020018	MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE	Feb 21, 2002	Substantially Equivalent	CARDIOPULMONARY CORP.
K013387	DATEX-OHMEDA S/5 WEB VIEWER	Jan 08, 2002	Substantially Equivalent	DATEX-OHMEDA
K013246	DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01	Dec 11, 2001	Substantially Equivalent	DATEX-OHMEDA
K012531	DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX	Nov 02, 2001	Substantially Equivalent	DATEX-OHMEDA
K013156	MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM	Oct 19, 2001	Substantially Equivalent	DATA CRITICAL CORP.
K012171	MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS	Jul 24, 2001	Substantially Equivalent	VISICU, INC.
K012005	MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM	Jul 24, 2001	Substantially Equivalent	DATA CRITICAL CORP.
K011999	MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM	Jul 24, 2001	Substantially Equivalent	DATA CRITICAL CORP.
K010912	ALARMVIEW WIRELESS DATA NETWORK SYSTEM	Apr 05, 2001	Substantially Equivalent	DATA CRITICAL CORP.
K003998	FLEXVIEW CLINICAL MONITORING SYSTEM	Mar 07, 2001	Substantially Equivalent	DATA CRITICAL CORP.
K001972	ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK	Oct 27, 2000	Substantially Equivalent	VISICU, INC.
K000647	DATEX-OHMEDA NETWORK AND CENTRAL	Jul 13, 2000	Substantially Equivalent	DATEX-OHMEDA, INC.
K994430	IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM	Mar 28, 2000	Substantially Equivalent	GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K992749	ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841	Jan 14, 2000	Substantially Equivalent	SPACELABS MEDICAL, INC.
K992848	ALARMVIEW SYSTEM	Nov 19, 1999	Substantially Equivalent	DATA CRITICAL CORP.
K990378	STATVIEW SYSTEM	Sep 20, 1999	Substantially Equivalent	DATA CRITICAL CORP.
K982342	DINAMAP MPS SELECT PORTABLE MONITOR	Aug 14, 1998	Substantially Equivalent	CRITIKON COMPANY,LLC
K973527	CARDIO-PAGER SYSTEM	Mar 31, 1998	Substantially Equivalent	DATA CRITICAL CORP.
K973640	TS2000 MEDICAL DEVICE MONITOR	Mar 12, 1998	Substantially Equivalent	TRINCORE SYSTEMS, INC.
K973318	MOBIMED SYSTEM, (PEGASUS AND POLARIS)	Feb 19, 1998	Substantially Equivalent	ORTIVUS US, INC.
K974101	DATEX-ENGSTROM NETWORK	Feb 06, 1998	Substantially Equivalent	DATEX-ENGSTROM, INC.
K974567	HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER	Jan 20, 1998	Substantially Equivalent	HEWLETT-PACKARD CO.
K971868	IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM	Nov 13, 1997	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K962473	(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH	Nov 06, 1997	Substantially Equivalent - Subject to Tracking Reg.	DATA CRITICAL CORPORATION
K972880	MDP2000 MEDICAL DATA PROCESSOR	Oct 22, 1997	Substantially Equivalent	VIDCO, INC.
K971683	WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET	Oct 22, 1997	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K971569	DINAMAP MPS PORTABLE MONITOR	Sep 19, 1997	Substantially Equivalent	JOHNSON & JOHNSON MEDICAL, INC.

FEI Numbers

This FDA classification entry is associated with 70 FEI numbers. Click on an entry to view related FDA registrations.

1000122786: 38 registrations

1218950: 64 registrations

1316463: 77 registrations

1831750: 29 registrations

2080783: 62 registrations

2183613: 23 registrations

2221819: 65 registrations

3000126629: 658 registrations

3000976525: 10 registrations

3001084824: 32 registrations

3001104093: 90 registrations

3002737156: 19 registrations

3002806783: 51 registrations

3002807167: 118 registrations

3002807720: 63 registrations

3003142870: 3 registrations

3003263092: 14 registrations

3003971136: 58 registrations

3004526608: 19 registrations

3005783425: 35 registrations

3006104191: 9 registrations

3006240053: 4 registrations

3006254866: 6 registrations

3007413079: 4 registrations

3007481893: 10 registrations

3007603826: 123 registrations

3008729547: 71 registrations

3008855170: 2 registrations

3008952681: 2 registrations

3009077524: 178 registrations

3009156722: 110 registrations

3009443693: 11 registrations

3009595635: 1 registration

3009673645: 9 registrations

3009831876: 17 registrations

3009973336: 99 registrations

3010157426: 51 registrations

3010694760: 1 registration

3010698831: 8 registrations

3010703925: 45 registrations

3011166598: 1 registration

3011353843: 55 registrations

3011696573: 1 registration

3012359877: 31 registrations

3012528160: 30 registrations

3013500228: 47 registrations

3013501110: 54 registrations

3013546957: 9 registrations

3013596024: 49 registrations

3013783488: 23 registrations

3013896610: 16 registrations

3014541700: 17 registrations

3014856521: 9 registrations

3015134004: 11 registrations

3015173634: 1 registration

3015280546: 4 registrations

3015437214: 2 registrations

3015529350: 7 registrations

3016595211: 1 registration

3016618143: 63 registrations

3016670256: 3 registrations

3016701404: 34 registrations

3016852448: 62 registrations

3017935637: 1 registration

3018188848: 3 registrations

3019388613: 52 registrations

3023530182: 48 registrations

3026576087: 14 registrations

3027510187: 1 registration

6736: 24 registrations