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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 K123581
Device Name NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
Applicant
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
6135 Gunbarrel Ave
BOULDER,  CO  80301
Applicant Contact MIA M WARE
Correspondent
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
6135 Gunbarrel Ave
BOULDER,  CO  80301
Correspondent Contact MIA M WARE
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/20/2012
Decision Date 05/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
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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