510(k) K984524

AZTECH 70 by Villa Sistemi Medicali S.P.A. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1999
Date Received
December 21, 1998
Clearance Type
Special
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