K232507
- 510(k) number
- K232507
- Device name
- Aerogen®Solo Nebulizer System
- Applicant
- Aerogen, Ltd. IE
- Product code
- CAF — Nebulizer (Direct Patient Interface)
- Decision date
- 2024-05-10
- Date received
- 2023-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K232507.pdf
Official FDA record: K232507
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.