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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 K083325
Device Name N-600X WITH SPD, OXIMAX N-600X
Applicant
COVIDIEN
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Applicant Contact SCOTT D DICKERHOFF
Correspondent
COVIDIEN
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Correspondent Contact SCOTT D DICKERHOFF
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/12/2008
Decision Date 03/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT00775346
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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