FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
Nio Color 8MP (MDNC-8132)
K Number: K233693
·
Decision Dec 11, 2023
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
134
Applicant Total
60
Review Days
24
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Basic Information
- Device Name
- Nio Color 8MP (MDNC-8132)
- K Number
- K233693
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Barco N.V.
- Date Received
- November 17, 2023
- Decision Date
- December 11, 2023
- Product Code
- PGY
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | FDA class 2 | Radiology |
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