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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K160718
Device Name Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
Applicant
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80301
Applicant Contact Timothy Holwick
Correspondent
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80301
Correspondent Contact Timothy Holwick
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DXJ   OUG  
Date Received03/15/2016
Decision Date 11/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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