FDA 510(k) Application Details - K070195

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K070195
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	BROADSOUND CORPORATION 5F, NO.31 SHINTAI ROAD JUIPEI CITY, HSINCHU 30252 TW Other 510(k) Applications for this Company
Contact	JIANN HWA JENG, PHD 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	01/22/2007
Decision Date	10/15/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review