Data / Medical devices / Australia / Fink Engineering Pty Ltd
Fink Engineering Pty Ltd: FDA-registered device maker in Laverton North Victoria, Australia, 2 510(k) clearances
Fink Engineering Pty Ltd is registered with the FDA (registration 3006097795) in Laverton North Victoria, Australia. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006097795
- Address
- 2/26 Westside Drive, Laverton North Victoria, Australia, 3026
- Owner or operator
- FINK ENGINEERING PTY LTD (9056584)
- Roles
- Manufacturer
- First device listed
- October 3, 2006
- Registered through
- 2026
- Brand names listed
- CILITY, DL8, Fink Hyperbaric Chamber, SL8, TL20 HYPERBARIC OXYGEN TREATMENT FA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Hyperbaric | CBF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 21, 2024 | K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | CBF | Substantially Equivalent | Fink Engineering Pty, Ltd. | accessdata.fda.gov |
| December 5, 2003 | K031649 | SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES | CBF | Substantially Equivalent | Fink Engineering Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.