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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 K223721
Device Name Masimo Stork
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Sindura Penubarthi
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Sindura Penubarthi
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
FLL  
Date Received12/12/2022
Decision Date 12/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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