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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 K212161
Device Name Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Katelynn Kirby
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Kertana Shankar
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
BZQ   CCK   DPZ   DQA   DXN  
FLL   JKS  
Date Received07/12/2021
Decision Date 03/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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