MDPC-8127
FDA 510(k) clearance K203364 · decided 2021-04-15
Clearance details
- K-number
- K203364
- Device name
- MDPC-8127
- Applicant
- Barco N.V.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-16
- Decision date
- 2021-04-15
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- PSY
- Device class
- 2
- Regulation number
- 864.3700
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- 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.