FDA 510(k) Application Details - K131830

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K131830
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	EDAN INSTRUMENTS, INC. EQUIPMENTS PARK, NANHAI RD 1019 NO. SHEKOU NANSHAN SHENZHEN 518067 CN Other 510(k) Applications for this Company
Contact	CHERRY SUN Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2013
Decision Date	09/17/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review