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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, programmable
510(k) Number K210822
Device Name DeepRhythmAI
Medicalgorithmics S.A.
Aleje Jerozolimskie 81
Warsaw,  PL 02-001
Applicant Contact Marek Dziubinski
Medicalgorithmics US Holding Corporation
2711 Centerville Road, Suite 400
Wilmington,  DE  19808
Correspondent Contact Agnieszka Romowicz
Regulation Number870.1425
Classification Product Code
Subsequent Product Code
Date Received03/19/2021
Decision Date 07/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No