FDA 510(k) Application Details - K961116

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K961116
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	MEDASONICS, INC. 9712 S. ALTAMONT DR. SANDY, UT 84092 US Other 510(k) Applications for this Company
Contact	WILLIAM E MCKAY 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	03/20/1996
Decision Date	08/08/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review