MASK, DISPOSABLE OXYGEN THERAPY
Device Facts
| Record ID | K760329 |
|---|---|
| Device Name | MASK, DISPOSABLE OXYGEN THERAPY |
| Applicant | Inhal-O-Tech Medical Plastic |
| Product Code | BYG · Anesthesiology |
| Decision Date | Sep 30, 1976 |
| 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.
