FDA 510(k) Application Details - K092837

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K092837
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	OPKO INSTRUMENTATION, INC 4400 BISCAYNE BLVD MIAMI, FL 33137 US Other 510(k) Applications for this Company
Contact	MARIO ARBESU Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2009
Decision Date	12/23/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review