BI IMAGE-X EVOLUTION— 510(k) K160458
Substantially EquivalentRadiotecnologia Industrial S.A. DE C.V.
FDA 510(k) clearance K160458 for BI IMAGE-X EVOLUTION, Substantially Equivalent on 2016-06-20. Applicant: Radiotecnologia Industrial S.A. DE C.V.. Device class: 2.
Clearance details
- Applicant
- Radiotecnologia Industrial S.A. DE C.V.
- Product code
- Code EHD
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ixtapaluca, MX
Recent devices under product code EHD
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