DEN230067 is an FDA 510(k) submission for the Chronos®. This device is classified as a Ultraviolet Radiation Disinfection Chamber Device (Class II - Special Controls, product code SCS).
Submitted by Germitec (Bordeaux, FR). The FDA issued a Not Cleared (DENG) decision on August 28, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6511. An Ultraviolet Radiation Disinfection Chamber Device Is Intended To Disinfect Patient Contacting Medical Devices Using Uv Radiation After The Device Has Been Cleaned. Disinfection Of The Medical Device Is Achieved Within An Enclosed Chamber Through The Exposure To Uv Radiation..
| 510(k) Number | DEN230067 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 28, 2023 |
| Decision Date | August 28, 2024 |
| Days to Decision | 335 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | SCS - Ultraviolet Radiation Disinfection Chamber Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6511 |
| Definition | An Ultraviolet Radiation Disinfection Chamber Device Is Intended To Disinfect Patient Contacting Medical Devices Using Uv Radiation After The Device Has Been Cleaned. Disinfection Of The Medical Device Is Achieved Within An Enclosed Chamber Through The Exposure To Uv Radiation. |