COMBO MASK
Device Facts
| Record ID | K941336 |
|---|---|
| Device Name | COMBO MASK |
| Applicant | Gam Industries, Inc. |
| Product Code | KGB · Anesthesiology |
| Decision Date | Sep 9, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5570 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.
