The following data is part of a premarket notification filed by Neuronetrix Solutions with the FDA for Cognision Eeg/ep System.
| Device ID | K141316 |
| 510k Number | K141316 |
| Device Name: | COGNISION EEG/EP SYSTEM |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | NEURONETRIX SOLUTIONS 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701 |
| Contact | Cheryl Fisher |
| Correspondent | Cheryl Fisher NEURONETRIX SOLUTIONS 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701 |
| Product Code | OLT |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-20 |
| Decision Date | 2015-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B706H10000 | K141316 | 000 |