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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K193626
Device Name Masimo Rad-97 Pulse CO-Oximeter and Accessories
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Linus Park
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Linus Park
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
BZQ   CCK   DPZ   DQA   DXN  
FLL  
Date Received12/26/2019
Decision Date 08/10/2020
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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