510(k) K222822— VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

Substantially Equivalent

Draegerwerk AG & CO Kgaa

Clearance details

Applicant: Draegerwerk AG & CO Kgaa
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 2022-09-19
Decision date: 2023-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.