Nio Color 2MP (MDNC-2123)
FDA 510(k) clearance K171812 · decided 2017-07-19
Clearance details
- K-number
- K171812
- Device name
- Nio Color 2MP (MDNC-2123)
- Applicant
- Barco N.V.
- Decision
- Substantially Equivalent
- Date received
- 2017-06-19
- Decision date
- 2017-07-19
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- PGY
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kortrijk, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.