510(k) DEN230067
DEN230067 is an FDA 510(k) premarket notification submitted by Germitec for the device "Chronos®". The FDA issued a decision of De Novo Granted on Aug 28, 2024. The device falls under product code SCS (Ultraviolet Radiation Disinfection Chamber Device), a Class II device regulated under 21 CFR 880.6511.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Aug 28, 2024
- Date Received
- Sep 28, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultraviolet Radiation Disinfection Chamber Device
- Device Class
- Class II
- Regulation Number
- 880.6511
- Review Panel
- HO
- Submission Type
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.