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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 K252474
Device Name Withings BeamO (SCT02)
Applicant
Withings
2 Rue Maurice Hartmann
Issy-Les-Moulineaux,  FR 92130
Applicant Contact Aline Criton
Correspondent
Withings
2 Rue Maurice Hartmann
Issy-Les-Moulineaux,  FR 92130
Correspondent Contact Aline Criton
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DQD   SDV  
Date Received08/06/2025
Decision Date 11/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT06351761
NCT06637878
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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