ROBINJECT
Device Facts
| Record ID | K864984 |
|---|---|
| Device Name | ROBINJECT |
| Applicant | International Medical Products, Inc. |
| Product Code | KZE · General Hospital |
| Decision Date | Jun 29, 1987 |
| 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.
