FDA 510(k) Application Details - K970782

Device Classification Name	System, X-Ray, Fluoroscopic, Non-Image-Intensified   More FDA Info for this Device
510(K) Number	K970782
Device Name	System, X-Ray, Fluoroscopic, Non-Image-Intensified
Applicant	GENERAL ROBOTIC DEVICES, INC. 2069 GOLFSIDE DR. YPSILANTI, MI 48197 US Other 510(k) Applications for this Company
Contact	YANSONG SHAN Other 510(k) Applications for this Contact
Regulation Number	892.1660   More FDA Info for this Regulation Number
Classification Product Code	JAB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/1997
Decision Date	11/13/1997
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