GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
Device Facts
| Record ID | K001409 |
|---|---|
| Device Name | GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER |
| Applicant | Hyperbaric Technologies, Inc. |
| Product Code | CBF · Anesthesiology |
| Decision Date | Aug 2, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5470 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).
