K240696 is an FDA 510(k) clearance for the Airdog X8 Air Purifier (KJ800F-X8). This device is classified as a Cleaner, Air, Medical Recirculating (Class II - Special Controls, product code FRF).
Submitted by Suzhou Beiang Smart Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on June 14, 2024, 92 days after receiving the submission on March 14, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5045.
| 510(k) Number | K240696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2024 |
| Decision Date | June 14, 2024 |
| Days to Decision | 92 days |
| Submission Type | Special |
| 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 |