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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 K172482
Device Name The Nellcor pulse oximetry monitor interface cable
Applicant
Covidien
6135 Gunbarrel Avenue
Boulder,  CO  80301
Applicant Contact Mia M. Ware
Correspondent
Covidien
6135 Gunbarrel Avenue
Boulder,  CO  80301
Correspondent Contact Mia M. Ware
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/16/2017
Decision Date 12/15/2017
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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