510(k) K881701

RADKOR SFC-21 by Radkor, Inc. — Product Code IYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1988
Date Received
April 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Mount, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1770
Review Panel
RA
Submission Type