FDA 510(k) Application Details - K993763

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K993763
Device Name	System, X-Ray, Angiographic
Applicant	MEDIS MEDICAL IMAGING SYSTEMS, B.V. 109 DANBURY RD. RIDGEFIELD, CT 06877 US Other 510(k) Applications for this Company
Contact	DOUGLAS F ORR Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/1999
Decision Date	11/26/1999
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