PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM— 510(k) K131252

Substantially Equivalent

Covidien

FDA 510(k) clearance K131252 for PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM, Substantially Equivalent on 2014-02-24. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2013-05-02
Decision date: 2014-02-24
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.