X-MIND trium— 510(k) K160166
Substantially EquivalentDe 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.. Device class: 2.
Clearance details
- Applicant
- De Gotzen S.R.L.
- Product code
- Code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Olgiate Olona, IT
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