FDA 510(k) Application Details - K053325

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K053325
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	MEDIWATCH LTD SWIFT HOUSE, SWIFT VALLEY INDUSTRIAL ESATE, RUGBY WARWICKSHIRE CV 21 IQN GB Other 510(k) Applications for this Company
Contact	ANDREW HOPKINS 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	12/01/2005
Decision Date	12/07/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review