FDA 510(k) Application Details - K191110

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K191110
Device Name	Monitor, Ultrasonic, Fetal
Applicant	HeraMED Ltd. 6 Meir Ariel St. Netanya 4059300 IL Other 510(k) Applications for this Company
Contact	Dganit Litinsky Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	KNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2019
Decision Date	11/14/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review