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
Sep 26, 2000K002030OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
Invivo Research, Inc.
MWI
Aug 2, 2000K002009HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
Agilent Technologies, Inc.
MWI
Jul 13, 2000K001265WELCH ALLYN INSTRUMENT INTERFACE MODULE
Welch Allyn, Inc.
MWI
Jun 30, 2000K001776MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
Agilent Technologies, Inc.
MWI
Apr 28, 2000K0010208100 VITAL SIGNS MONITOR
Criticare Systems, Inc.
MWI
Mar 20, 2000K000635MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
Agilent Technologies, Inc.
MWI
Feb 24, 2000K992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
Critikon Company, LLC
MWI
Feb 11, 2000K983928KODAK HOME HEALTH MONITORING SYSTEM
Eastman Kodak Company
MWI
Mar 16, 1999K980688INTEGRITI PATIENT MONITOR
Alliance Instruments
MWI

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