STER-O-MIST 1000 ML
Device Facts
| Record ID | K821191 |
|---|---|
| Device Name | STER-O-MIST 1000 ML |
| Applicant | Inhalation Therapy Equipment, Co. |
| Product Code | CAF · Anesthesiology |
| Decision Date | May 13, 1982 |
| 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.