K240569 is an FDA 510(k) clearance for the FESL FINK Chamber. This device is classified as a Chamber, Hyperbaric (Class II - Special Controls, product code CBF).
Submitted by Fink Engineering Pty, Ltd. (Warana, AU). The FDA issued a Cleared decision on November 21, 2024, 266 days after receiving the submission on February 29, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5470.
| 510(k) Number | K240569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 2024 |
| Decision Date | November 21, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBF - Chamber, Hyperbaric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5470 |