510(k) K223835
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2023
- Date Received
- December 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleaner, Air, Medical Recirculating
- Device Class
- Class II
- Regulation Number
- 880.5045
- Review Panel
- HO
- Submission Type