K251584
- 510(k) number
- K251584
- Device name
- Medical Mesh Nebulizer (AirICU Max+)
- Applicant
- AIRICU, Inc. CA · US
- Product code
- SFP — Ventilator-Compatible Nebulizer
- Decision date
- 2026-03-12
- Date received
- 2025-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K251584
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.