FDA 510(k) Application Details - K110482

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K110482
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	TERATECH CORP. P.O. BOX 10074 13221 NE TEEM LOOP ROAD BAINBRIDGE ISLAND, WA 98110 US Other 510(k) Applications for this Company
Contact	CHARLES F HOTTINGER 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	02/18/2011
Decision Date	03/18/2011
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