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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 K223013
Device Name AccurECG Analysis System
AccurKardia, Inc.
101 Avenue of Americas, Floor 8
New York,  NY  10013
Applicant Contact Juan C. Jimenez
Hyman, Phelps & McNamara, PC
700 Thirteenth Street, N.W.
Suite 1200
Washington,  DC  20005 -5929
Correspondent Contact Kwame Ulmer
Regulation Number870.2340
Classification Product Code
Subsequent Product Code
Date Received09/29/2022
Decision Date 06/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No