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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Oximeter
510(k) Number K141518
FOIA Releasable 510(k) K141518
Device Name Nellcor Bedside Respiratory Patient Monitoring System
Applicant
COVIDIEN
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Applicant Contact JAMIE THOMAS
Correspondent
COVIDIEN
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Correspondent Contact JAMIE THOMAS
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
BZQ  
Date Received06/09/2014
Decision Date 03/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT01804062
NCT01837537
NCT02075346
Reviewed by Third Party No
Combination Product No
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