STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
Device Facts
| Record ID | K901301 |
|---|---|
| Device Name | STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL |
| Applicant | Automatic Liquid Packaging, Inc. |
| Product Code | CAF · Anesthesiology |
| Decision Date | May 31, 1990 |
| 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.
