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510(k) K231055

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) by De Götzen S.R.L. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2023
Date Received
April 13, 2023
Clearance Type
Abbreviated
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

Other clearances by De Götzen S.R.L.

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