NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON— 510(k) K910019

Substantially Equivalent

Novametrix Medical Systems, Inc.

FDA 510(k) clearance K910019 for NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON, Substantially Equivalent on 1991-03-26. Applicant: Novametrix Medical Systems, Inc..

Clearance details

Applicant: Novametrix Medical Systems, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1991-01-03
Decision date: 1991-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, 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.