FDA 510(k) Application Details - K081873

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K081873
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	SHENZHEN EMPEROR ELECTRONIC TECHNOLOGY CO. LTD. TIAN'AN NANYOU INDUSTRIAL AREA NANSHAN DISTRICT SHENZHEN 518054 CN Other 510(k) Applications for this Company
Contact	CHENG GUIYUAN 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	07/02/2008
Decision Date	07/16/2008
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	Y
Expedited Review