Puritan Bennett 980 Series Ventilator System— 510(k) K193056

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K193056 for Puritan Bennett 980 Series Ventilator System, Substantially Equivalent on 2020-11-20. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2019-11-01
Decision date: 2020-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.