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 IDK160718
510k NumberK160718
Device Name:Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant COVIDIEN 6135 Gunbarrel Avenue Boulder,  CO  80301
ContactTimothy Holwick
CorrespondentTimothy Holwick
COVIDIEN 6135 Gunbarrel Avenue Boulder,  CO  80301
Product CodeMWI  
Subsequent Product CodeDXJ
Subsequent Product CodeOUG
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-15
Decision Date2016-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521795273 K160718 000
10884521762619 K160718 000
10884521795150 K160718 000
10884521795143 K160718 000
10884521829855 K160718 000
10884521835962 K160718 000
10884521835870 K160718 000
10884521844933 K160718 000
10884521845176 K160718 000
10884521780668 K160718 000
10884521806740 K160718 000
10884521812208 K160718 000
10884521809246 K160718 000
10884521810334 K160718 000
10884521815810 K160718 000
10884521757127 K160718 000
10884521818965 K160718 000
10884521823372 K160718 000
10884521829848 K160718 000
10884521844940 K160718 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.