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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850011306168 | K110967 | 000 |
| 00867718000278 | K110967 | 000 |
| 00867718000261 | K110967 | 000 |
| 00850011306352 | K110967 | 000 |
| 00850011306161 | K110967 | 000 |
| 00850011306147 | K110967 | 000 |
| 00850011306130 | K110967 | 000 |
| 00850011306062 | K110967 | 000 |
| 00850011306055 | K110967 | 000 |
| 00850011306048 | K110967 | 000 |
| 00850011306512 | K110967 | 000 |
| 00850011306673 | K110967 | 000 |
| 00850011306024 | K110967 | 000 |
| 10850011306144 | K110967 | 000 |
| 10850011306069 | K110967 | 000 |
| 10850011306052 | K110967 | 000 |
| 10850011306045 | K110967 | 000 |
| 10850011306359 | K110967 | 000 |
| 10850011306137 | K110967 | 000 |
| 00850011306185 | K110967 | 000 |
| 00850011306178 | K110967 | 000 |
| 00850011306031 | K110967 | 000 |
| 00850011306734 | K110967 | 000 |