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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name angiographic coronary vascular physiologic simulation software
510(k) Number K192442
Device Name FFRangio
CathWorks Ltd
3 Rapaport Street
Kfar-Saba,  IL 4465141
Applicant Contact Asaf Azulay
Heyer Regulatory Solutions LLC
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number870.1415
Classification Product Code
Date Received09/06/2019
Decision Date 12/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No