FDA 510(k) Application Details - K153475

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K153475
Device Name	Monitor, Ultrasonic, Fetal
Applicant	EDAN INSTRUMENTS, INC. 3/F - B, NANSHAN MEDICAL EQUIPMENT PARK, NANHAI RD 1019# SHENZHEN 518067 CN Other 510(k) Applications for this Company
Contact	QUEENA CHEN 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	12/02/2015
Decision Date	01/29/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review