FDA 510(k) Application Details - K962606

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K962606
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	I.Z.I. MEDICAL PRODUCTS CORP. 10 STREAM COURT OWINGS MILLS, MD 21117 US Other 510(k) Applications for this Company
Contact	S. JAMES ZINREICH Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/1996
Decision Date	08/07/1996
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