Aerogen®Solo Nebulizer System— 510(k) K232507

Substantially Equivalent

Aerogen, Ltd.

FDA 510(k) clearance K232507 for Aerogen®Solo Nebulizer System, Substantially Equivalent on 2024-05-10. Applicant: Aerogen, Ltd..

Clearance details

Applicant: Aerogen, Ltd.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2023-08-18
Decision date: 2024-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dangan Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.