SLEEPAP MASK
Device Facts
| Record ID | K894642 |
|---|---|
| Device Name | SLEEPAP MASK |
| Applicant | Medical Industries America, Inc. |
| Product Code | BYG · Anesthesiology |
| Decision Date | Oct 19, 1989 |
| 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.
