FDA 510(k) Application Details - K964806

Device Classification Name	Device, Spot-Film   More FDA Info for this Device
510(K) Number	K964806
Device Name	Device, Spot-Film
Applicant	FISCHER IMAGING CORP. 2301 WINDSOR CT. ADDISON, IL 60101 US Other 510(k) Applications for this Company
Contact	WILLIAM J ENGEL Other 510(k) Applications for this Contact
Regulation Number	892.1670   More FDA Info for this Regulation Number
Classification Product Code	IXL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/1996
Decision Date	03/04/1997
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	N
Expedited Review