510(k) K211507
K211507 is an FDA 510(k) premarket notification submitted by Beiang Air Tech , Ltd. for the device "Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)". The FDA issued a decision of Substantially Equivalent on November 22, 2022. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2022
- Date Received
- May 14, 2021
- 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