FDA 510(k) Application Details - K050363

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K050363
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C REDMOND, WA 98052-4911 US Other 510(k) Applications for this Company
Contact	LARRY D WALKER Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2005
Decision Date	02/17/2005
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	N
Expedited Review