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 27, 2019K191059Masimo Rad-97 and Accessories
Masimo Corporation
MWI
Dec 8, 2019K190273T3 Platform software
Etiometry, Inc.
MWI
Sep 25, 2019K183687LifeWindow LW8 Lite
Digicare Biomedical Technology, Inc.
MWI
Sep 11, 2019K183370PeraMobile and PeraWatch
Perahealth, Inc.
MWI
Aug 28, 2019K182401B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) The
Amzetta Technologies Private Limited, IN
MWI
Aug 2, 2019K190090DynoSense Vital Sign Measuring System
Dynosense Corp.
MWI
May 28, 2019K190468Nihon Kohden SVM-7200 Series Vital Signs Monitor
Nihon Kohden Corporation, JP
MWI
May 15, 2019K183697Masimo Rad-97 and Accessories
Masimo Corporation
MWI
Apr 17, 2019K183638SmartLinx Vitals Plus Patient Monitoring System
Capsule Technologie
MWI
Apr 17, 2019K183634Stasis Monitoring System
Stasis Labs, Inc.
MWI
Apr 16, 2019K181541Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth N
Andon Health Co, Ltd., CN
MWI
Apr 5, 2019K181919Patient Monitor
Guangdong Biolight Meditech Co., Ltd., CN
MWI
Mar 29, 2019K1809033880 MRI Patient Monitoring System
Iradimed Corporation
MWI
Mar 27, 2019K182821Accutorr 7/VS-900/VS-900c Vital Signs Monitor
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MWI
Dec 17, 2018K172965Handheld VitalSigns Monitoring System
Visiomed Technology Co.,Ltd, CN
MWI
Dec 14, 2018K1829003880 MRI Patient Monitoring System
Iradimed Corporation
MWI
Dec 6, 2018K183116Unity Network ID
GE Healthcare
MWI
Sep 11, 2018K182226AirStrip RPM InvisionHeart Adapter
Airstrip Technologies, Inc.
MWI
Sep 7, 2018K181311Philips Hemodynamic Application R1.0
Philips Medical Systems Nederlands B.V., NL
MWI
Aug 8, 2018K180734SmartLinx Vitals Plus Patient Monitoring System
Capsule Technologie
MWI
Jun 6, 2018K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100
Taidoc Technology Corporation, TW
MWI
May 25, 2018K172147STAR 65
Skanray Technologies Pvt, Ltd., IN
MWI
May 1, 2018K172959PeraServer and PeraTrend
Perahealth, Inc.
MWI
Feb 5, 2018K171361BETTERCARE PLATFORM - ADVANCED WEB CLIENT
Better Care S.L., ES
MWI
Jan 4, 2018K171056WAVE Clinical Platform
Excel Medical Electronics, LLC
MWI
Nov 17, 2017K171121Masimo Root Monitoring System and Accessories
Masimo Corporation
MWI
Oct 25, 2017K1722003880 MRI Patient Monitoring System
Iradimed Corporation
MWI
Oct 24, 2017K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm H
Capsule Technologie Sas
MWI
Oct 17, 2017K170538RVS-100 Vital Signs Monitor
Rudolf Riester GmbH, DE
MWI
Sep 14, 2017K170168Masimo Rad-97 and Accessories
Masimo Corporation
MWI
Sep 9, 2017K170047All-in-One Health Monitor, PC-303
Shenzhen Creative Industry Co., Ltd., CN
MWI
Sep 8, 2017K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
Fysicon BV, NL
MWI
Aug 2, 2017K170712Accutorr 7/VS-900 Vital Signs Monitor
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., CN
MWI
Jul 14, 2017K170798Dictum Health
Dictum Health, Inc.
MWI
Jun 22, 2017K160899CoVa Monitoring System 2
Tosense, Inc.
MWI
May 26, 2017K163065T3 Software
Etiometry, Inc.
MWI
May 12, 2017K170199Unity Network ID
GE Healthcare
MWI
Jan 4, 2017K162234Truscope Ultra Patient Monitor
Guangdong Biolight Meditech Co., Ltd., CN
MWI
Nov 17, 2016K161909IQvitals Zone
Midmark Corporation
MWI
Nov 14, 2016K160718Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
Covidien
MWI
Sep 9, 2016K151839AMC Health VitalCaregiving System
Amc Health
MWI
Jul 6, 2016K160956LD-Oxi system
Ld Technology, LLC
MWI
Jun 28, 2016K153739MRI Patient Monitor TeslaDUO
Mipm Mammendorfer Institut Fur Physik Und Medizin, DE
MWI
Jun 21, 2016K153225Masimo Root Monitoring System and Accessories
Masimo Corporation
MWI
Mar 17, 2016K153079Axeo 3 Patient Monitor
Axeo Medical Technologies, LLC
MWI
Mar 15, 2016K153335AlertWatch: OR
Alertwatch, LLC
MWI
Feb 25, 2016K153135VITAL SIGNS MONITOR
Guangdong Biolight Meditech Co., Ltd., CN
MWI
Feb 14, 2016K151512Star 60
Skanray Technologies Private Limited, IN
MWI
Feb 12, 2016K151644Masimo Root Vital Signs Monitoring System and Accessories
Masimo Corporation
MWI
Feb 9, 2016K152645Dictum Health
Dictum Health, Inc.
MWI

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