The following data is part of a premarket notification filed by Eurolink Llc. with the FDA for Neurotherm, Model Jk4.
| Device ID | K011387 |
| 510k Number | K011387 |
| Device Name: | NEUROTHERM, MODEL JK4 |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | EUROLINK LLC. 77 LOCKSLEY RD. Lynnfield, MA 01940 |
| Contact | William Rittman |
| Correspondent | William Rittman EUROLINK LLC. 77 LOCKSLEY RD. Lynnfield, MA 01940 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2001-09-06 |