NEUROTHERM, MODEL JK4
Device Facts
| Record ID | K011387 |
|---|---|
| Device Name | NEUROTHERM, MODEL JK4 |
| Applicant | Eurolink, LLC |
| Product Code | GXI · Neurology |
| Decision Date | Sep 6, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4725 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.