FDA 510(k) Application Details - K011611

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K011611
Device Name	System, Tomography, Computed, Emission
Applicant	DANISH DIAGNOSTIC DEVELOPMENT A/S DR. NEERGAARDSVEJ 5F 2970 HORSHOM 2970 DK Other 510(k) Applications for this Company
Contact	NIELS S ORENSEN Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/25/2001
Decision Date	06/08/2001
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