HTU3— 510(k) K984313

Substantially Equivalent

Hyox Systems , Ltd.

FDA 510(k) clearance K984313 for HTU3, Substantially Equivalent on 1999-10-22. Applicant: Hyox Systems , Ltd..

Clearance details

Applicant: Hyox Systems , Ltd.
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 1998-12-02
Decision date: 1999-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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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.