DRSplus— 510(k) K213705
Substantially EquivalentCentervue S.P.A.
FDA 510(k) clearance K213705 for DRSplus, Substantially Equivalent on 2021-12-21. Applicant: Centervue S.P.A.. Device class: 2.
Clearance details
- Applicant
- Centervue S.P.A.
- Product code
- Code MYC
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Padova, IT
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