FDA 510(k) Application Details - K081919

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K081919
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	FUKUDA DENSHI CO., LTD. 17725 N.E. 65TH STREET BLDG C REDMOND, WA 98052-4911 US Other 510(k) Applications for this Company
Contact	LORAN VAN NOY 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	07/07/2008
Decision Date	09/09/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review