FDA 510(k) Application Details - K112692

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K112692
Device Name	Accelerator, Linear, Medical
Applicant	HUMEDIQ GMBH BAHNHOFSTRABE 108 GRAFELFING 82166 DE Other 510(k) Applications for this Company
Contact	MORITZ HOYER 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	09/15/2011
Decision Date	08/03/2012
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