System, Network And Communication, Physiological Monitors

Product Code: MSX

Cardiovascular Microwave Medical Products

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 870.2300


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as MSX

888System, Network And Communication, Physiological MonitorsCardiac Monitor (including Cardiotachometer And Rate Alarm).

Total Product Life Cycle (TPLC) Devices

888System, Network And Communication, Physiological MonitorsCardiac Monitor (including Cardiotachometer And Rate Alarm).

FDA Consensus Standards

System, Network And Communication, Physiological Monitors [33227]21 CFR §870.2300 🔎
System, Network And Communication, Physiological Monitors [31353]21 CFR §870.2300 🔎
System, Network And Communication, Physiological Monitors [32430]21 CFR §870.2300 🔎

Pre-market Notifications for MSX

K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., LTD
K212622Zyter RPMZyter, Inc.
K211949AirStrip ONE Web Client With Alarm Communication Management (ACM)AirStrip Technologies, Inc.
K211046ECareManager 4.5Visicu, Inc.
K210160AlertWatch:ACAlertWatch, Inc.
K210133Current Health Monitoring System Gen 2 (G2)Current Health
K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.
K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.
K193421Smart Alarm InterfaceBoxView, LLC
K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-medical Electronics Co., LTD.
K193043Critical Alert CommonPath EnterpriseCritical Alert
K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/b/a Spire Health
K191272Wearable Device, Wearable PackageCurrent Health Ltd.
K190073Wearable Device, Home Package In Carry Case With Homehub, Home Package In Carry Case Without HomehubCurrent Health Ltd
K183238BeneVision Central Monitoring SystemShenzhen Mindray Bio-medical Electronics Co., LTD.

Global Unique Device Identification Database

00884838087965System, network and communication, physiological monitors
00884838087453System, network and communication, physiological monitors
00884838081284SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
00884838059832System,Network And Communication,Physiological Monitors
00884838059368System,Network And Communication,Physiological Monitors
00884838059313SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
00884838053441SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
00884838041530System,Network And Communication,Physiological Monitors
00884838040878System,Network And Communication,Physiological Monitors
00884838040861System,Network And Communication,Physiological Monitors
00884838031746SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
00883873952863SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
00883873952856SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
00883873923177SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
00883873908815SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS

Maude Adverse Events

CAREEVENT REL A.0PHILIPS MEDICAL SYSTEMS2020-03-27
CAREEVENT REL A.0PHILIPS MEDICAL SYSTEMS2020-03-04
CAREEVENT REL A.0PHILIPS MEDICAL SYSTEMS2020-02-05
PATIENT SAFETYNETTM SYSTEMMASIMO - 52 DISCOVERY2020-01-30
BENEVISION CENTRAL MONITORING SYSTEMSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD2020-01-30
BENEVISION CENTRAL MONITORING SYSTEMSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD2020-01-30
SAMSUNGVISICU, INC - DUP2020-01-22
ASCOMASCOM US, INC.2020-01-22
MINDRAY MPM MULTI PARAMETER MODULESHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD2020-01-22
INTELLIVUE PATIENT INFORMATION CENTER (PIC IX)PHILIPS NORTH AMERICA CORPORATION2020-01-22
PATIENT SAFETYNET CONSOLEMASIMO CORPORATION2020-01-03
SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS2019-10-07
INTELLIVUE PIIC IXPHILIPS ELECTRONICS NORTH AMERICA CORPORATION2019-10-02
INTELLISPHERE EVENT MANAGEMENTPHILIPS MEDICAL SYSTEMS2019-09-26
SAFETYNETMASIMO CORPORATION2019-09-11
CAREEVENT REL A.0PHILIPS MEDICAL SYSTEMS2019-08-27
ASCOMASCOM (SWEDEN) AB2019-08-09
ASCOMASCOM (SWEDEN) AB2019-07-11
INTELLISPHERE EVENT MANAGEMENTPHILIPS MEDICAL SYSTEMS2019-06-21
INTELLISPHERE EVENT MANAGEMENTPHILIPS MEDICAL SYSTEMS2019-06-11
EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0PHILIPS MEDICAL SYSTEMS2019-05-13
MONITORING SYSTEMVOCERA COMMUNICATIONS, INC.2019-05-07
MONITORING SYSTEMVOCERA COMMUNICATIONS, INC.2019-05-07
VOCERA COMMUNICATION DEVICEVOCERA COMMUNICATIONS, INC.2019-03-20
BERNOULLI MANAGEMENT SYSTEMMEDIANA CO. LTD.2019-02-28
BENEVISION CENTRAL MONITORING SYSTEMSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD2019-01-04
EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0PHILIPS MEDICAL SYSTEMS2018-11-14
INTELLISPHERE EVENT MANAGEMENTPHILIPS MEDICAL SYSTEMS2018-08-21
ASCOM MOBILE MONITORING GATEWAY (MMG)ASCOM SWEDEN AB2018-08-20
INFUSION SUPPORTDR?GERWERK AG & CO. KGAA2018-07-18
BENEVISION CENTRAL MONITORING SYSTEMSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD2018-06-20
BENEVISION CENTRAL MONITORING SYSTEMSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD2018-06-18
BENEVISION CENTRAL MONITORING SYSTEMSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD2018-06-07
BENEVISION CENTRAL MONITORING SYSTEMSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD2018-06-06
ECAREMANAGER SYSTEMVISICU, INC - DUP2018-05-15
CAREEVENT REL A.0PHILIPS MEDICAL SYSTEMS2018-04-26
INTELLISPHERE EVENT MANAGEMENTPHILIPS MEDICAL SYSTEMS2018-04-12
BENEVISION CENTRAL MONITORING SYSTEMSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD2018-03-23
CAREEVENT REL A.0PHILIPS MEDICAL SYSTEMS2018-03-21
EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0PHILIPS MEDICAL SYSTEMS2018-02-08
INTELLISPHERE EVENT MANAGEMENTPHILIPS MEDICAL SYSTEMS2018-01-24
CAREEVENT REL A.0PHILIPS MEDICAL SYSTEMS2017-11-28
INTELLIVUE TRX+PHILIPS2017-10-25
TELEMETRYSPACELABS2017-10-18
INTELLIVUEPHILIPS MEDICAL SYSTEMS2017-10-16
VOCERA COMMUNICATION DEVICEVOCERA COMMUNICATION2017-09-19
SPACELABS CLINICAL ACCESS/ ICSSPACELABS2017-08-10
BENEVISION CENTRAL MONITORING SYSTEMSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS, LTD.2017-06-07
BENEVISION CENTRAL MONITORING SYSTEMSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD2017-05-10
BENEVISION CENTRAL MONITORING SYSTEMSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS, LTD.2017-04-19
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