SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES— 510(k) K031649

Name: FDA 510(k) clearance K031649
Creator: U.S. Food and Drug Administration
Published: 2003-12-05

Substantially Equivalent

Fink Engineering Pty, Ltd.

FDA 510(k) clearance K031649 for SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES, Substantially Equivalent on 2003-12-05. Applicant: Fink Engineering Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Fink Engineering Pty, Ltd.
Product code: Code CBF
Device class: Class 2
Regulation: 21 CFR 868.5470
Advisory panel: Anesthesiology
Date received: 2003-05-28
Decision date: 2003-12-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBF

product code CBF

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.