510(k) K851095

INTRAORAL DENTAL X-RAY SYSTEM 70-X by Trophy Radiologie — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1985
Date Received
March 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type