OECO NASAL CANNULA— 510(k) K811789

Substantially Equivalent

Oeco

FDA 510(k) clearance K811789 for OECO NASAL CANNULA, Substantially Equivalent on 1981-07-02. Applicant: Oeco.

Clearance details

Applicant: Oeco
Product code: Code CAT
Advisory panel: Anesthesiology
Date received: 1981-06-24
Decision date: 1981-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CAT

product code CAT

Death: 5
Malfunction: 544
Other: 2
Total: 551

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.