OXYGEN MASKS 81420, 81421, 81471 & 81461
Device Facts
| Record ID | K913383 |
|---|---|
| Device Name | OXYGEN MASKS 81420, 81421, 81471 & 81461 |
| Applicant | Specialty Packaging Producs, Inc. |
| Product Code | BYG · Anesthesiology |
| Decision Date | Oct 18, 1991 |
| 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.