HYPEX(TM) JET INJECTOR
Device Facts
| Record ID | K945873 |
|---|---|
| Device Name | HYPEX(TM) JET INJECTOR |
| Applicant | Equidyne Systems, Inc. |
| Product Code | KZE · General Hospital |
| Decision Date | Aug 18, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5430 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.
