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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 K123002
Device Name VITAL SYNC SYSTEM
Applicant
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
6135 Gunbarrel Ave
BOULDER,  CO  80301
Applicant Contact KELSEY LEE
Correspondent
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
6135 Gunbarrel Ave
BOULDER,  CO  80301
Correspondent Contact KELSEY LEE
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/27/2012
Decision Date 02/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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