K251615
- 510(k) number
- K251615
- Device name
- Aerogen Pro-X1 Controller System
- Applicant
- Aerogen, Ltd. IE
- Product code
- SFP — Ventilator-Compatible Nebulizer
- Decision date
- 2025-09-02
- Date received
- 2025-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.2 MB · U.S. public domain
Also available from FDA: K251615.pdf
Official FDA record: K251615
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.