Evita V800, Evita V600— 510(k) K222024

Substantially Equivalent

Draegerwerk AG & CO Kgaa

FDA 510(k) clearance K222024 for Evita V800, Evita V600, Substantially Equivalent on 2023-05-16. Applicant: Draegerwerk AG & CO Kgaa.

Clearance details

Applicant: Draegerwerk AG & CO Kgaa
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2022-07-11
Decision date: 2023-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

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.