510(k) K161860— TG-970P CO2 Sensor Kit

Substantially Equivalent

Nihon Kohden Corporation

Clearance details

Applicant: Nihon Kohden Corporation
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2016-07-06
Decision date: 2017-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

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.