FDA 510(k) Application Details - K012887

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K012887
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	MEDISON AMERICA, INC. 16303 PANORAMIC WAY SAN LEANDRO, CA 94578-1116 US Other 510(k) Applications for this Company
Contact	GARY J ALLSEBROOK 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	08/28/2001
Decision Date	09/12/2001
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