FDA 510(k) Application Details - K113304

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K113304
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	MEDA CO. LTD. 13505 BROADFIELD DR. POTOMAC, MD 20854 US Other 510(k) Applications for this Company
Contact	KAI CHEN 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	11/08/2011
Decision Date	03/23/2012
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