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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 K221260
Device Name CSF-3
Applicant
Cardiacsense
Leshem 6-8
North Industrial Park
Caesarea,  IL
Applicant Contact Benita Lanzer
Correspondent
RQM+
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Oxana S. Pantchenko
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/02/2022
Decision Date 01/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05322382
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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