K240569
- 510(k) number
- K240569
- Device name
- FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
- Applicant
- Fink Engineering Pty, Ltd. AU
- Product code
- CBF — Chamber, Hyperbaric
- Decision date
- 2024-11-21
- Date received
- 2024-02-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K240569.pdf
Official FDA record: K240569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.