FDA 510(k) Application Details - K101960

Device Classification Name	Monitor, Blood-Flow, Ultrasonic   More FDA Info for this Device
510(K) Number	K101960
Device Name	Monitor, Blood-Flow, Ultrasonic
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	YUE QIUHONG Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	HEP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2010
Decision Date	08/10/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review