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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 K252361
Device Name AccurECG Analysis System (v2.0)
Applicant
Accurkardia, Inc.
101 Ave. Of The Americas
Suite 931
New York,  NY  10013
Applicant Contact Juan Jimenez
Correspondent
Medtech Impact Partners
16844 Margate St.
Encino,  CA  91436
Correspondent Contact Kwame Ulmer
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DQK  
Date Received07/29/2025
Decision Date 12/22/2025
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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