510(k) K935004

MODEL ALPHA TS-2 by Dpa Consulting, Inc. — Product Code IYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1993
Date Received
October 19, 1993
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