CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
Device Facts
| Record ID | K895231 |
|---|---|
| Device Name | CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER |
| Applicant | Hudson Oxygen Therapy Sales Co. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Oct 27, 1989 |
| 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.
