Clearance Summary
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) received FDA 510(k) clearance under submission number K211507, sponsored by Beiang Air Tech , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2022-11-22.
- Submission: K211507
- Applicant / Sponsor: Beiang Air Tech , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5045
- Decision date: 2022-11-22
Classification & Regulation
This clearance is catalogued under FDA product code FRF and 21 CFR 880.5045, within the General Hospital review panel as a Class II device.