FDA 510(k) Application Details - K033316

Device Classification Name	Couch, Radiation Therapy, Powered   More FDA Info for this Device
510(K) Number	K033316
Device Name	Couch, Radiation Therapy, Powered
Applicant	BRAINLAB AG AMMERTHALSTRASSE 8 HEIMSTETTEN 85551 DE Other 510(k) Applications for this Company
Contact	RAINER BIRKENBACH Other 510(k) Applications for this Contact
Regulation Number	892.5770   More FDA Info for this Regulation Number
Classification Product Code	JAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2003
Decision Date	05/14/2004
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