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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 K201770
Device Name Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Katelynn Kirby
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Katelynn Kirby
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
BZQ   DPZ  
Date Received06/29/2020
Decision Date 09/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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