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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K241380
Device Name FETOLY-HEART
Applicant
Diagnoly
60 Ave. Rockefeller
Lyon,  FR 69008
Applicant Contact Ivan Voznyuk
Correspondent
MCRA, LLC
505 Park Ave., 14th Floor
New York,  NY  10022
Correspondent Contact Nima Akhlaghi
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
IYO   QIH  
Date Received05/15/2024
Decision Date 09/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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