DeviceClearance

K800869

Substantially Equivalent

MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA

Applicant
Cavitron Corp.
Product code
CCK
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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.