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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 K130796
Device Name VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
Applicant
COVIDIEN
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Applicant Contact KELSEY LEE
Correspondent
COVIDIEN
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Correspondent Contact KELSEY LEE
Regulation Number870.2300
Classification Product Code
MWI  
Date Received03/22/2013
Decision Date 05/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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