The following data is part of a premarket notification filed by Neurotherm, Inc. with the FDA for Nt-1000.
| Device ID | K052878 |
| 510k Number | K052878 |
| Device Name: | NT-1000 |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | NEUROTHERM, INC. 2 DEBUSH AVE. BUILDING A2 Middleton, MA 01949 |
| Contact | William Rittman |
| Correspondent | William Rittman NEUROTHERM, INC. 2 DEBUSH AVE. BUILDING A2 Middleton, MA 01949 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-12 |
| Decision Date | 2006-01-23 |