The following data is part of a premarket notification filed by Neuralynx Inc with the FDA for Enterprise Electrophysiology System.
| Device ID | K110967 |
| 510k Number | K110967 |
| Device Name: | ENTERPRISE ELECTROPHYSIOLOGY SYSTEM |
| Classification | Reduced- Montage Standard Electroencephalograph |
| Applicant | NEURALYNX INC 105 COMMERCIAL DRIVE Bozeman, MT 59715 -2217 |
| Contact | Mike Johnson |
| Correspondent | Mike Johnson NEURALYNX INC 105 COMMERCIAL DRIVE Bozeman, MT 59715 -2217 |
| Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-06 |
| Decision Date | 2011-06-30 |