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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 K120773
Device Name NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
Applicant
Covidien LLC
77325 JOYCE WAY
ECHO,  OR  97826 -.
Applicant Contact CHARLIE MACK
Correspondent
Covidien LLC
77325 JOYCE WAY
ECHO,  OR  97826 -.
Correspondent Contact CHARLIE MACK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/14/2012
Decision Date 07/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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