510(k) K083510

KUBTEC XPERT 20 by Kub Technologies, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2009
Date Received
November 26, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type