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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(with arrhythmia detection or alarms)
510(k) Number K223498
Device Name Radius VSM and Accessories
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 Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   DPS   DPZ   DQA   DQK  
DRT   DSI   DSJ   DXN   DXQ   FLL  
KMI  
Date Received11/21/2022
Decision Date 06/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04676152
Reviewed by Third Party No
Combination Product No
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