Chronos®
FDA 510(k) clearance DEN230067 · decided 2024-08-28
Clearance details
- K-number
- DEN230067
- Device name
- Chronos®
- Applicant
- Germitec
- Decision
- Unknown
- Date received
- 2023-09-28
- Decision date
- 2024-08-28
- Days to decision
- 335 days
- Clearance type
- Direct
- Product code
- SCS
- Device class
- 2
- Regulation number
- 880.6511
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bordeaux, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UV Smart D60 (K251354) | UV Smart Technologies B.V. | 2026-01-29 |
Recalls involving this device
No recalls on record reference this clearance.