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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 K232389
Device Name Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Kertana Shankar
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Kertana Shankar
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/09/2023
Decision Date 09/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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