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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 K221953
Device Name Masimo CARESCAPE SpO2 – Masimo with SpHb
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Unji Lee
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Unji Lee
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/05/2022
Decision Date 08/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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