ProVee Video Processing Unit (PV-003)
FDA 510(k) clearance K251734 · decided 2025-09-24
Clearance details
- K-number
- K251734
- Device name
- ProVee Video Processing Unit (PV-003)
- Applicant
- Proverum Limited
- Decision
- Substantially Equivalent
- Date received
- 2025-06-06
- Decision date
- 2025-09-24
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- FET
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Dublin 1, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.