510(k) DEN230067
- Device
- Chronos®
- Applicant
- Germitec
- 510(k) number
- DEN230067
- Product code
- SCS
- Decision
- Unknown (DENG)
- Decision date
- 2024-08-28
- Date received
- 2023-09-28
- Regulation
- 880.6511
- Classification name
- Ultraviolet Radiation Disinfection Chamber Device
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Vincent Gardes
- Address
- 19 Rue Vauban Bordeaux FR 33000 33000
FDA Registration Numbers#
- 3030303856
- 3030794592
- 2084725
- 3004491421
- 3021233712
- 3019817713
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SCS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251354 | UV Smart D60 | UV Smart Technologies B.V. | 2026-01-29 |