COMOACT ULTRASONIC NEBULIZER, MODEL 3060
Device Facts
| Record ID | K002543 |
|---|---|
| Device Name | COMOACT ULTRASONIC NEBULIZER, MODEL 3060 |
| Applicant | San UP S.A. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Jun 14, 2001 |
| 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.
