VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM

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

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Vital Sync Informatics Manager & Virtual Patient Monitoring Platform.

Pre-market Notification Details

Device IDK132604
510k NumberK132604
Device Name:VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant COVIDIEN 6135 GUNBARREL AVE. Boulder,  CO  80301
ContactKelsey Lee
CorrespondentKelsey Lee
COVIDIEN 6135 GUNBARREL AVE. Boulder,  CO  80301
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-20
Decision Date2013-12-04
Summary:summary

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