x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)— 510(k) K231055

Name: FDA 510(k) clearance K231055
Creator: U.S. Food and Drug Administration
Published: 2023-12-28

Substantially Equivalent

De Götzen S.R.L.

FDA 510(k) clearance K231055 for x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology), Substantially Equivalent on 2023-12-28. Applicant: De Götzen S.R.L.. Device class: 2.

Clearance details

Applicant: De Götzen S.R.L.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2023-04-13
Decision date: 2023-12-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Fagnano Olona, IT

Download summary PDF View on FDA.gov ↗

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