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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 K201179
Device Name GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
Covidien llc
6135 Gunbarrel Avenue
Boulder,  CO  80301
Applicant Contact Ligia Mastronardi
Covidien llc
6135 Gunbarrel Avenue
Boulder,  CO  80301
Correspondent Contact Ligia Mastronardi
Regulation Number870.2700
Classification Product Code
Date Received05/01/2020
Decision Date 07/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No