FDA 510(k) Application Details - K981535

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K981535
Device Name	Accelerator, Linear, Medical
Applicant	COMPUTERIZED MEDICAL SYSTEMS, INC. 1195 CORPORATE LAKE DR. ST. LOUIS, MO 63132-1716 US Other 510(k) Applications for this Company
Contact	MICHAEL A PARSONS Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/1998
Decision Date	04/02/1999
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