GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)
Device Facts
| Record ID | K914271 |
|---|---|
| Device Name | GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) |
| Applicant | C.G.H. Medical, Inc. |
| Product Code | CAN · Anesthesiology |
| Decision Date | Apr 13, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2700 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
