510(k) K243815
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2025
- Date Received
- December 11, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Respiratory Accessory Microbial Reduction Device.
- Device Class
- Class II
- Regulation Number
- 880.6993
- Review Panel
- HO
- Submission Type
A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturers cleaning instructions.