The following data is part of a premarket notification filed by Neurotherm, Inc. with the FDA for Nt 2000 Lesioning Generator.
| Device ID | K111576 |
| 510k Number | K111576 |
| Device Name: | NT 2000 LESIONING GENERATOR |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | NEUROTHERM, INC. 200 Homer Ave Ashland, MA 01721 |
| Contact | F. David Rothkopf |
| Correspondent | F. David Rothkopf NEUROTHERM, INC. 200 Homer Ave Ashland, MA 01721 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-06 |
| Decision Date | 2011-09-20 |
| Summary: | summary |