510(k) K251354
- Device
- UV Smart D60
- Applicant
- UV Smart Technologies B.V.
- 510(k) number
- K251354
- Product code
- SCS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-29
- Date received
- 2025-04-30
- Regulation
- 880.6511
- Classification name
- Ultraviolet Radiation Disinfection Chamber Device
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Thijs Kea
- Address
- Patrijsweg 74 Rijswijk NL 2289EX 2289EX
FDA Registration Numbers#
- 3030303856
- 3030794592
- 2084725
- 3004491421
- 3021233712
- 3019817713
Source Documents#
Other 510(k) Records For Product Code SCS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230067 | Chronos® | Germitec | 2024-08-28 |