Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)— 510(k) K230520
Substantially EquivalentBarco N.V.
FDA 510(k) clearance K230520 for Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521), Substantially Equivalent on 2023-03-21. Applicant: Barco N.V.. Device class: 2.
Clearance details
- Applicant
- Barco N.V.
- Product code
- Code PGY
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kortrijk, BE
Recent devices under product code PGY
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