CUSHION FLEX(TM)
Device Facts
| Record ID | K884387 |
|---|---|
| Device Name | CUSHION FLEX(TM) |
| Applicant | Life Design Systems, Inc. |
| Product Code | BSJ · Anesthesiology |
| Decision Date | Nov 17, 1988 |
| 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.