BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
Device Facts
| Record ID | K002565 |
|---|---|
| Device Name | BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE) |
| Applicant | Baylis Medical Co., Inc. |
| Product Code | GXD · Neurology |
| Decision Date | May 3, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.