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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Fetal
510(k) Number K191110
Device Name HeraBEAT™ US
Applicant
HeraMED Ltd.
6 Meir Ariel St.
Netanya,  IL 4059300
Applicant Contact Dganit Litinsky
Correspondent
Regulatory Solutions LLC
125 Cherry Lane
Amherst,  MA  91002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number884.2660
Classification Product Code
KNG  
Date Received04/26/2019
Decision Date 11/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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