FDA 510(k) Application Details - K964414

Device Classification Name	Camera, Multi Format, Radiological   More FDA Info for this Device
510(K) Number	K964414
Device Name	Camera, Multi Format, Radiological
Applicant	BAYER CORP., AGFA DIV. 100 CHALLENGER RD. RIDGEFIELD PARK, NJ 07660 US Other 510(k) Applications for this Company
Contact	MICHAEL SULLIVAN 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	11/05/1996
Decision Date	01/27/1997
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