DISPOSABLE FACE MASK
Device Facts
| Record ID | K896773 |
|---|---|
| Device Name | DISPOSABLE FACE MASK |
| Applicant | Cadema Medical Products, Inc. |
| Product Code | BYG · Anesthesiology |
| Decision Date | Jan 12, 1990 |
| 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.