SYSTEM 22 ADULT MASK
Device Facts
| Record ID | K940887 |
|---|---|
| Device Name | SYSTEM 22 ADULT MASK |
| Applicant | Medic-Aid , Ltd. |
| Product Code | BYG · Anesthesiology |
| Decision Date | Apr 19, 1994 |
| 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.
