TYPE EXPIRED CO2 9270, CAPNOGRAPH— 510(k) K895001

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K895001 for TYPE EXPIRED CO2 9270, CAPNOGRAPH, Substantially Equivalent on 1990-02-22. Applicant: S & W Medico Teknik.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1989-08-03
Decision date: 1990-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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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.