MINI STATCO2 CO2 DETECTOR, MODEL 10-55371— 510(k) K031411

Substantially Equivalent

Mercury Medical

FDA 510(k) clearance K031411 for MINI STATCO2 CO2 DETECTOR, MODEL 10-55371, Substantially Equivalent on 2003-07-30. Applicant: Mercury Medical.

Clearance details

Applicant: Mercury Medical
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2003-05-05
Decision date: 2003-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, 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.