FDA 510(k) Application Details - K060440

Device Classification Name	Camera, Multi Format, Radiological   More FDA Info for this Device
510(K) Number	K060440
Device Name	Camera, Multi Format, Radiological
Applicant	CODONICS, INC. 17991 ENGLEWOOD DR. MIDDLEBURG HEIGHTS, OH 44130 US Other 510(k) Applications for this Company
Contact	ALAN DESANTIS Other 510(k) Applications for this Contact
Regulation Number	892.2040   More FDA Info for this Regulation Number
Classification Product Code	LMC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2006
Decision Date	03/16/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review