DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA— 510(k) K961150

Substantially Equivalent

Hudson Respiratory Care, Inc.

FDA 510(k) clearance K961150 for DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA, Substantially Equivalent on 1996-09-10. Applicant: Hudson Respiratory Care, Inc..

Clearance details

Applicant: Hudson Respiratory Care, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1996-03-22
Decision date: 1996-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

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Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.