OXYGEN MASK, AIR-ENTRAINMENT
Device Facts
| Record ID | K772127 |
|---|---|
| Device Name | OXYGEN MASK, AIR-ENTRAINMENT |
| Applicant | Salter Labs |
| Product Code | BYF · Anesthesiology |
| Decision Date | Jan 3, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5600 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.
