OMRON ULTRASONIC NEBULIZER MODEL NE-UO5
Device Facts
| Record ID | K864466 |
|---|---|
| Device Name | OMRON ULTRASONIC NEBULIZER MODEL NE-UO5 |
| Applicant | Omron Tateisi Electronics Co. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Mar 26, 1987 |
| 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.