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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulse Oximeter For Over-The-Counter Use
510(k) Number K214115
FOIA Releasable 510(k) K214115
Device Name MightySat -OTC
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
OLK  
Date Received12/30/2021
Decision Date 01/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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