AIRSEP NEWLIFE AIR OUTLET OPTION
Device Facts
| Record ID | K944020 |
|---|---|
| Device Name | AIRSEP NEWLIFE AIR OUTLET OPTION |
| Applicant | Airsep Corp. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Mar 16, 1995 |
| 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.
