FDA 510(k) Application Details - K110999

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K110999
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	EDAN INSTRUMENTS, INC. 4/F, NEW ENERGY BLDG., 2009 NANYOU ROAD NANSHAN, GUANGDONG 518054 CN Other 510(k) Applications for this Company
Contact	RANDY JIANG Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2011
Decision Date	04/26/2011
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