FDA 510(k) Application Details - K973219

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K973219
Device Name	System, X-Ray, Stationary
Applicant	OLDELFT CORP. OF AMERICA 9108 GUILFORD RD. COLUMBIA, MD 21046 US Other 510(k) Applications for this Company
Contact	L. DON PHILLIPS Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/1997
Decision Date	10/08/1997
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