ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300
Device Facts
| Record ID | K951259 |
|---|---|
| Device Name | ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300 |
| Applicant | Impulso Trading Co. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Jun 20, 1995 |
| 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.
