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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
Applicant
AccurKardia, Inc.
101 Avenue of Americas, Floor 8
New York,  NY  10013
Applicant Contact Juan C. Jimenez
Correspondent
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
DPS  
Subsequent Product Code
DQK  
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
Predetermined Change
Control Plan Authorized		 No
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