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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 K232161
Device Name DeepRhythm Platform
Applicant
Medicalgorithmics S.A.
Aleje Jerozolimskie 81
Warsaw,  PL 02-001
Applicant Contact Maciej Gamrot
Correspondent
Medicalgorithmics US Holding Corporation
Corporation Service Company 251 Little Falls Dr.
Wilmington,  DE  19808
Correspondent Contact Joanna Dabala
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DQK  
Date Received07/20/2023
Decision Date 06/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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