FDA 510(k) Application Details - K000516

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K000516
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	GE MEDICAL SYSTEMS, INC. P.O. BOX 414 MILWAUKEE, WI 53201 US Other 510(k) Applications for this Company
Contact	ALLEN SCHUH 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	02/16/2000
Decision Date	04/19/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review