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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
510(k) Number K234021
Device Name Masimo Stork
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Kertana Shankar
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Kertana Shankar
Classification Product Code
QYU  
Subsequent Product Code
FLL  
Date Received12/20/2023
Decision Date 05/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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