Monitor, Ultrasonic, Fetal

HeraMED Ltd.

The following data is part of a premarket notification filed by Heramed Ltd. with the FDA for Herabeat™ Us.

Pre-market Notification Details

Device IDK191110
501k NumberK191110
Device Name:HeraBEAT™ US
ClassificationMonitor, Ultrasonic, Fetal
Applicant HeraMED Ltd. 6 Meir Ariel St. Netanya,  IL 4059300
ContactDganit Litinsky
CorrespondentSheila Hemeon-heyer
Regulatory Solutions LLC 125 Cherry Lane Amherst,  MA  91002
Product CodeKNG  
CFR Regulation Number884.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
501k Review PanelObstetrics/Gynecology
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-26
Decision Date2019-11-14

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