510(k) K251615
- Device
- Aerogen Pro-X1 Controller System
- Applicant
- Aerogen, Ltd.
- 510(k) number
- K251615
- Product code
- SFP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-02
- Date received
- 2025-05-27
- Regulation
- 868.5630
- Classification name
- Ventilator-Compatible Nebulizer
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Thelma Marley
- Address
- Galway Business Park Dangan Galway IE H91 HE94 H91 HE94
FDA Registration Numbers#
- 3018070843
- 3004127293
- 3014916466
- 3044320625
- 3003399703
Source Documents#
Other 510(k) Records For Product Code SFP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251584 | Medical Mesh Nebulizer (AirICU Max+) | AIRICU, Inc. | 2026-03-12 |