MDMC-12133
FDA 510(k) clearance K141428 · decided 2014-06-27
Clearance details
- K-number
- K141428
- Device name
- MDMC-12133
- Applicant
- Barco N.V.
- Decision
- Substantially Equivalent
- Date received
- 2014-05-30
- Decision date
- 2014-06-27
- Days to decision
- 28 days
- Clearance type
- Traditional
- 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.