FDA 510(k) Application Details - K083001

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K083001
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING,KEJI 12TH RD. SOUTH, HI-TECH INDUSTRIAL PARK NANSHAN, SHENZHEN, GUANGDONG 518057 CN Other 510(k) Applications for this Company
Contact	TAN CHUANBIN Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/2008
Decision Date	10/22/2008
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