CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER— 510(k) K133516

Substantially Equivalent

Flexicare

FDA 510(k) clearance K133516 for CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER, Substantially Equivalent on 2014-04-30. Applicant: Flexicare.

Clearance details

Applicant: Flexicare
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2013-11-15
Decision date: 2014-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mid Glam, GB

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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.