FDA 510(k) Application Details - K152303

Device Classification Name	Monitor, Patient Position, Light-Beam   More FDA Info for this Device
510(K) Number	K152303
Device Name	Monitor, Patient Position, Light-Beam
Applicant	GAMMEX, INC. 7600 DISCOVERY DRIVE MIDDLETON, WI 53562 US Other 510(k) Applications for this Company
Contact	Kenneth Windisch Other 510(k) Applications for this Contact
Regulation Number	892.5780   More FDA Info for this Regulation Number
Classification Product Code	IWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2015
Decision Date	09/11/2015
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