CUSHION-FLEX TM
Device Facts
| Record ID | K843169 |
|---|---|
| Device Name | CUSHION-FLEX TM |
| Applicant | Life Design Systems, Inc. |
| Product Code | BSJ · Anesthesiology |
| Decision Date | Aug 20, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5550 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.