FDA 510(k) Application Details - K034003

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K034003
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 BOTHELL, WA 98041 US Other 510(k) Applications for this Company
Contact	LYNN HARMER 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	12/24/2003
Decision Date	01/08/2004
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