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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 K212876
Device Name Carescape SpO2 - Masimo
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Kertana Shankar
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Kertana Shankar
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/09/2021
Decision Date 10/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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