X-MIND trium— 510(k) K160166

Substantially Equivalent

De Gotzen S.R.L.

FDA 510(k) clearance K160166 for X-MIND trium, Substantially Equivalent on 2016-11-15. Applicant: De Gotzen S.R.L..

Clearance details

Applicant: De Gotzen S.R.L.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2016-01-27
Decision date: 2016-11-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Olgiate Olona, IT

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