FDA 510(k) Application Details - K172780

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K172780
Device Name	Monitor, Ultrasonic, Fetal
Applicant	Edan Instruments Inc #15 Jinhui Road,Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen 518067 CN Other 510(k) Applications for this Company
Contact	Alice Yang 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	09/14/2017
Decision Date	06/06/2018
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