DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
Device Facts
| Record ID | K950314 |
|---|---|
| Device Name | DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) |
| Applicant | Dantec Medical, Inc. |
| Product Code | GXZ · Neurology |
| Decision Date | Mar 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1350 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.