K232642 is an FDA 510(k) clearance for the AirKEE T900. This device is classified as a Purifier, Air, Ultraviolet, Medical (Class II - Special Controls, product code FRA).
Submitted by Healkee Medical Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on May 23, 2024, 267 days after receiving the submission on August 30, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6500.
| 510(k) Number | K232642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2023 |
| Decision Date | May 23, 2024 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRA - Purifier, Air, Ultraviolet, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6500 |