FDA 510(k) Application Details - K081829

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K081829
Device Name	Camera, Scintillation (Gamma)
Applicant	DANISH DIAGNOSTIC DEVELOPMENT A/S DR. NEERGAARDSVEJ 5F HORSHOLM DK Other 510(k) Applications for this Company
Contact	NIELS SORENSEN 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	06/27/2008
Decision Date	07/11/2008
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	Y
Expedited Review