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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
Recalls CDRH Recalls
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