FDA 510(k) Application Details - K110601

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K110601
Device Name	Camera, Scintillation (Gamma)
Applicant	GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A CAMINO DE VERA S/N EDIFICIO 9B VALENCIA 46022 ES Other 510(k) Applications for this Company
Contact	SEVERINE MOINE Other 510(k) Applications for this Contact
Regulation Number	892.1100   More FDA Info for this Regulation Number
Classification Product Code	IYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2011
Decision Date	03/18/2011
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	Y
Expedited Review