ClearanceBrief
Panels › Cardiovascular › Product code MWI · Class 2

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Regulation 870.2300

6510(k)s in 12 months (309 all time)
11recalls in 12 months (85 all time)
80recalls that name a 510(k)
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Top companies in MWI

Company510(k)sRecalls
Invivo Corp.817
Ge Medical Systems Information Technologies126
Larsen & Toubro Limited150
Masimo Corporation130
Welch Allyn, Inc.120
Agilent Technologies, Inc.110
Philips Medical Systems100
Airstrip Technologies, Inc.90
Capsule Technologie90
Philips North America Llc09
Decided510(k)Device and applicantCode
Dec 23, 2015K152330Expression MR400 MRI Patient Monitoring System
Invivo Corporation
MWI
Dec 14, 2015K152341ViSi Mobile Monitoring System
Sotera Wireless, Inc.
MWI
Dec 10, 2015K150869Checkme Pro Health Monitor
Viatom Technology Co., Ltd., CN
MWI
Oct 29, 2015K151715T3 Software
Etiometry, Inc.
MWI
Oct 28, 2015K152124Tempus IC2
Remote Diagnostics Technologies, Ltd., GB
MWI
Sep 17, 2015K151071SmartLinx Vitals Plus Patient Monitoring System
Capsule Technologie Sas
MWI
Jun 17, 2015K150512STAR 90
Skanray Technologies Pvt, Ltd., IN
MWI
May 26, 2015K143304Sickbay Clinical Platform
Medical Informatics Corp
MWI
May 15, 2015K150691Datalys Multi-Parameter Patient Monitor
Lutech Industries, Inc.
MWI
May 8, 2015K150620740 SELECT
Cas Medical Systems, Inc.
MWI
May 7, 2015K142032MRI PATIENT MONITORING SYSTEM TESLA M3
Mipm Mammendorfer Institut Fur Physik Und Medizin, NL
MWI
May 1, 2015K142087COVA MONITORING SYSTEM
Tosense, Inc.
MWI
Apr 30, 2015K150361ViSi Mobile Monitoring System
Sotera Wireless, Inc.
MWI
Apr 2, 2015K143372AWARE
Ambient Clinical Analytics
MWI
Mar 4, 2015K142732T3 Software
Etiometry, Inc.
MWI
Feb 6, 2015K142244CLEO PATIENT MONITOR
Infinium Medical
MWI
Jan 23, 2015K143751Visi Mobile Monitoring System
Sotera Wireless, Inc.
MWI
Jan 18, 2015K142106DECISIO HEALTH PATIENT DASHBOARD
Decisio Health, Inc.
MWI
Jan 7, 2015K142840Unity Network ID
GE Healthcare
MWI
Dec 19, 2014K142356Connex Spot Monitor,901058 Vital Signs Monitor Core
Welch Allyn, Inc.
MWI
Nov 25, 2014K142394Masimo Root Monitoring System and Accesories
Masimo Corporation
MWI
Oct 30, 2014K133810VC150 VITAL SIGNS MONITOR
Innokas Yhtyma, FI
MWI
Aug 12, 2014K134014TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
Remote Diagnostic Technologies , Ltd., GB
MWI
Jun 25, 2014K140188MASIMO ROOT MONITORING SYSTEM
Masimo Corporation
MWI
Jun 13, 2014K140430740 SELECT
Cas Medical Systems, Inc.
MWI
Jun 6, 2014K131762HANDHELD MONITOR
Guangdong Biolight Meditech Co., Ltd., CN
MWI
May 16, 2014K133988TEMPUS PRO EXTENDED FEATURES
Remote Diagnostic Technologies , Ltd., GB
MWI
May 16, 2014K132037VITAL SIGNS MONITOR
Mindray North America
MWI
May 2, 2014K132038ACCUTORR 7 VITAL SIGNS MONITOR
Mindray North America
MWI
Apr 10, 2014K140339VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
Covidien
MWI
Feb 21, 2014K132229OMNI PATENT MONITORS
Infinium Medical
MWI
Feb 18, 2014K131898A SERIES AND Q SERIES PATIENT MONITORS
Guangdong Biolight Meditech Co., Ltd., CN
MWI
Feb 14, 2014K133450AIRSTRIP REMOTE PATIENT MONITORING
Airstrip Technologies, LP
MWI
Feb 6, 2014K133394AIRSTRIP REMOTE PATIENT MONITORING
Airstrip Technologies, LP
MWI
Jan 31, 2014K132807MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
Welch Allyn, Inc.
MWI
Dec 18, 2013K133586VISI MOBILE MONITIORING SYSTEM
Sotera Wireless, Inc.
MWI
Dec 5, 2013K131497MCKESSON CARDIOLOGY HEMO
Mckesson Israel , Ltd.
MWI
Dec 4, 2013K132604VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
Covidien
MWI
Dec 4, 2013K132033BM3/BM3 PLUS
Noblitt & Rueland
MWI
Nov 20, 2013K132808VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
Welch Allyn, Inc.
MWI
Oct 7, 2013K130709VISI MOBILE MONITORING SYSTEM
Sotera Wireless, Inc.
MWI
Oct 1, 2013K123711PATIENT MONITOR
Shenzhen Creative Industry Co., Ltd.
MWI
Aug 30, 2013K132359MRI PATIENT MONITORING SYSTEM
Invivo Corporation
MWI
Jul 23, 2013K130740NIGHTINGALE MONITORING SYSTEM
Zoe Medical, Inc.
MWI
Jul 15, 2013K131382EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL
Invivo Corporation
MWI
Jul 3, 2013K131786AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
Airstrip Technologies, LP
MWI
Jun 21, 2013K124038BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)
Bedside Clinical Systems, Inc.
MWI
Jun 5, 2013K130773TEMPUS PRO PATIENT MONITOR
Remote Diagnostic Technologies , Ltd., GB
MWI
May 29, 2013K130411740 SELECT
Cas Medical Systems, Inc.
MWI
May 9, 2013K130796VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
Covidien
MWI

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