DeviceClearance

K161860

Substantially Equivalent

TG-970P CO2 Sensor Kit

Applicant
Nihon Kohden Corporation
Product code
CCK
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tokyo, JP
Download summary PDF View on FDA.gov ↗

Adverse events under product code CCK

product code CCK
Death
3
Malfunction
11,428
Total
11,431

Source: openFDA MAUDE database, through . 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.