MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA— 510(k) K800869

Substantially Equivalent

Cavitron Corp.

FDA 510(k) clearance K800869 for MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA, Substantially Equivalent on 1980-05-28. Applicant: Cavitron Corp..

Clearance details

Applicant: Cavitron Corp.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1980-04-17
Decision date: 1980-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.