EVOLUTION 3E VENTILATOR— 510(k) K113743

Substantially Equivalent

Event Medical, Inc.

FDA 510(k) clearance K113743 for EVOLUTION 3E VENTILATOR, Substantially Equivalent on 2012-12-18. Applicant: Event Medical, Inc..

Clearance details

Applicant: Event Medical, Inc.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2011-12-20
Decision date: 2012-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, 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.