Deka Bluebeam
FDA 510(k) clearance K243683 · decided 2025-06-12
Clearance details
- K-number
- K243683
- Device name
- Deka Bluebeam
- Applicant
- El.En S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-29
- Decision date
- 2025-06-12
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Calenzano, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.