END TIDAL CO2 NASAL CANNULA— 510(k) K120518

Name: FDA 510(k) clearance K120518
Creator: U.S. Food and Drug Administration
Published: 2012-05-04

Substantially Equivalent

Care Fusion

FDA 510(k) clearance K120518 for END TIDAL CO2 NASAL CANNULA, Substantially Equivalent on 2012-05-04. Applicant: Care Fusion. Device class: 2.

Clearance details

Applicant: Care Fusion
Product code: Code CCK
Device class: Class 2
Regulation: 21 CFR 868.1400
Advisory panel: Anesthesiology
Date received: 2012-02-21
Decision date: 2012-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, US

Download summary PDF View on FDA.gov ↗

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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.