FDA 510(k) Application Details - K061827

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K061827
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	UltraSonix Medical Corporation 310-3480 GILMORE WAY BURNABY, BRITISH COLUMBIA V5G 4Y1 CA Other 510(k) Applications for this Company
Contact	LULIA NUCA 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	06/28/2006
Decision Date	08/04/2006
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	N
Expedited Review