MMPC-4127F1
FDA 510(k) clearance K172922 · decided 2017-12-21
Clearance details
- K-number
- K172922
- Device name
- MMPC-4127F1
- Applicant
- Barco N.V.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-25
- Decision date
- 2017-12-21
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- PZZ
- 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.