VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER
Device Facts
| Record ID | K911759 |
|---|---|
| Device Name | VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER |
| Applicant | Vortran Medical Technology 1, Inc. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Sep 10, 1991 |
| 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.
