FDA 510(k) Application Details - K102138

Device Classification Name	Monitor, Fetal Doppler Ultrasound   More FDA Info for this Device
510(K) Number	K102138
Device Name	Monitor, Fetal Doppler Ultrasound
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	LIU YONGYING Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	MAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2010
Decision Date	10/28/2010
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