510(k) K251584
- Device
- Medical Mesh Nebulizer (AirICU Max+)
- Applicant
- AIRICU, Inc.
- 510(k) number
- K251584
- Product code
- SFP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-12
- Date received
- 2025-05-23
- Regulation
- 868.5630
- Classification name
- Ventilator-Compatible Nebulizer
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Jay Li
- Address
- 220 N California Suite A City Of Industry CA US 91744 91744
FDA Registration Numbers
- 3003399703
- 3014916466
- 3004127293
- 3018070843
- 3044320625
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SFP
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251615 | Aerogen Pro-X1 Controller System | Aerogen, Ltd. | 2025-09-02 |