FDA 510(k) Application Details - K000987

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K000987
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	LIFECARE IMAGING INTL., LTD. 8411 PYOTT RD. LAKE IN THE HILLS, IL 60102 US Other 510(k) Applications for this Company
Contact	RICHARD A ADAMS Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2000
Decision Date	06/01/2000
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