510(k) K953563

VANGUARD XR-350 CINEANGIOGRAM PROJECTOR by Jamieson Film Co. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1995
Date Received
July 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type