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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 K230812
Device Name Withings Scan Monitor 2.0
2 rue Maurice Hartmann
Issy-Les-Moulineaux,  FR 92130
Applicant Contact Khushboo Surendran
2 rue Maurice Hartmann
Issy-Les-Moulineaux,  FR 92130
Correspondent Contact Khushboo Surendran
Regulation Number870.2340
Classification Product Code
Subsequent Product Code
Date Received03/24/2023
Decision Date 08/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05266235
Reviewed by Third Party No
Combination Product No