FDA 510(k) Application Details - K980308

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K980308
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	ECHOTECH 3D IMAGING SYSTEMS GMBH P.O. BOX 218 INDIAN HILLS, CO 80454 US Other 510(k) Applications for this Company
Contact	KEVIN MORNINGSTAR 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	01/27/1998
Decision Date	05/06/1998
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	N
Expedited Review