PEDIATRIC OXYGEN OR AEROSOL MASKS,
Device Facts
| Record ID | K802323 |
|---|---|
| Device Name | PEDIATRIC OXYGEN OR AEROSOL MASKS, |
| Applicant | Airlife, Inc. |
| Product Code | BYG · Anesthesiology |
| Decision Date | Oct 3, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5580 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
