ANALYZER-PLUG-IN, CO2 MODEL M 3104— 510(k) K780107

Substantially Equivalent

Electronics For Medicine, Inc.

FDA 510(k) clearance K780107 for ANALYZER-PLUG-IN, CO2 MODEL M 3104, Substantially Equivalent on 1978-01-30. Applicant: Electronics For Medicine, Inc..

Clearance details

Applicant: Electronics For Medicine, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1978-01-19
Decision date: 1978-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.