FDA 510(k) Application Details - K093714

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K093714
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	MEDISON CO., LTD. 997-10 DAECHI-DONG GANGNAM-GU SEOUL 135-280 KR Other 510(k) Applications for this Company
Contact	KYUNG AM SHIM 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	12/02/2009
Decision Date	12/10/2009
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