510(k) K900007

R-100-ET MANUAL COLLIMATOR by Advantech — Product Code IZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1990
Date Received
January 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Manual, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type