FDA 510(k) Application Details - K011111

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K011111
Device Name	System, X-Ray, Stationary
Applicant	MODULAR X-RAY DEVICES P.O. BOX 2878 HONEYDEW 2040 ROODEPOORT 2040 ZA Other 510(k) Applications for this Company
Contact	S.B.B. DESEMBERG 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	04/11/2001
Decision Date	05/30/2001
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