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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K240229
Device Name Masimo W1
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Sindura Penubarthi
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Sindura Penubarthi
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DQA   DXH  
Date Received01/29/2024
Decision Date 08/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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