Submission Details
| 510(k) Number | K240569 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
Nov 2024
Decision
266d
Days
Class 2
Risk
About This 510(k) Submission
K240569 is an FDA 510(k) clearance for the FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber, 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 review panel. Regulated under 21 CFR 868.5470.
Device Classification
| Product Code | CBF — Chamber, Hyperbaric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5470 |
Manufacturer
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