DEKA SMARTPERIO
FDA 510(k) clearance K203396 · decided 2021-08-23
Clearance details
- K-number
- K203396
- Device name
- DEKA SMARTPERIO
- Applicant
- El.En Electronic Engineering Spa
- Decision
- Substantially Equivalent
- Date received
- 2020-11-18
- Decision date
- 2021-08-23
- Days to decision
- 278 days
- Clearance type
- Traditional
- Product code
- NVK
- 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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Recalls involving this device
No recalls on record reference this clearance.