FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
Device Facts
| Record ID | K260270 |
|---|---|
| Device Name | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) |
| Applicant | FindAir Sp. z o.o. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Jun 2, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.
