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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 K201456
Device Name Scan Monitor
Applicant
Withings SA
2 rue Maurice Hartmann
issy-les-moulineaux,  FR 92130
Applicant Contact debreuil xavier
Correspondent
Withings SA
2 rue Maurice Hartmann
issy-les-moulineaux,  FR 92130
Correspondent Contact debreuil xavier
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DQA   DXH  
Date Received06/01/2020
Decision Date 10/05/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT04351386
Reviewed by Third Party No
Combination Product No
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