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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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