AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000
Device Facts
| Record ID | K914465 |
|---|---|
| Device Name | AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 |
| Applicant | Pegasus Research Corp. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Mar 31, 1992 |
| 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.
