FDA 510(k) Application Details - K954884

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K954884
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	VINGMED SOUND, INC. 1592 HARBOR RD. WILLIAMSBURG, VA 23185 US Other 510(k) Applications for this Company
Contact	WALTER E GUNDAKER 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	10/23/1995
Decision Date	05/28/1996
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