K211507 is an FDA 510(k) clearance for the Airdog X5 Recirculating Air Cleaner (model KJ300F-X5). This device is classified as a Cleaner, Air, Medical Recirculating (Class II - Special Controls, product code FRF).
Submitted by Beiang Air Tech , Ltd. (Suzhou, CN). The FDA issued a Cleared decision on November 22, 2022, 557 days after receiving the submission on May 14, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5045.
| 510(k) Number | K211507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2021 |
| Decision Date | November 22, 2022 |
| Days to Decision | 557 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRF - Cleaner, Air, Medical Recirculating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5045 |