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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 K212555
Device Name Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
Applicant
Covidien, LLC
6135 Gunbarrel Ave.
Boulder,  CO  80301
Applicant Contact Anushka Jayaraman
Correspondent
Covidien, LLC
6135 Gunbarrel Ave.
Boulder,  CO  80301
Correspondent Contact Greeshma Kayala
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/13/2021
Decision Date 05/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT04559763
NCT04811963
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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