FDA 510(k) Application Details - K061488

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K061488
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI 7263 CRONIN CIRCLE DUBLIN, CA 94568 US Other 510(k) Applications for this Company
Contact	BOB LEIKER 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	05/31/2006
Decision Date	06/30/2006
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