The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Neuromap With Neuro 100.
| Device ID | K002773 |
| 510k Number | K002773 |
| Device Name: | NEUROMAP WITH NEURO 100 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 |
| Contact | Nancy C Macdonald |
| Correspondent | Nancy C Macdonald RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-06 |
| Decision Date | 2000-10-23 |