STERILE SUBDERMAL NEEDLE ELECTRODES
Device Facts
| Record ID | K010019 |
|---|---|
| Device Name | STERILE SUBDERMAL NEEDLE ELECTRODES |
| Applicant | Nicolet Biomedical, Inc. |
| Product Code | GXZ · Neurology |
| Decision Date | Mar 19, 2001 |
| Decision | SESE |
| Submission Type | Abbreviated |
| 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.
