840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION— 510(k) K092847

Substantially Equivalent

Covidien, Formerly Nellcor Puritan Bennett, Inc.

FDA 510(k) clearance K092847 for 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION, Substantially Equivalent on 2010-03-11. Applicant: Covidien, Formerly Nellcor Puritan Bennett, Inc..

Clearance details

Applicant: Covidien, Formerly Nellcor Puritan Bennett, Inc.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2009-09-16
Decision date: 2010-03-11
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.