CBF
- Product code
- CBF
- Device name
- Chamber, Hyperbaric
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5470
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 69 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240569 | 2024-11-21 | Fink Engineering Pty, Ltd. | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Cham… | FDA |
Official FDA classification page: CBF
Classification and pathway per current FDA publications. Data from openFDA (CC0).