The following data is part of a premarket notification filed by Neurowave Systems Inc. with the FDA for Discovereeg System, Model De-401.
| Device ID | K142834 |
| 510k Number | K142834 |
| Device Name: | DiscoverEEG System, Model DE-401 |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | NeuroWave Systems Inc. 2490 Lee Blvd, Suite 300 Cleveland Heights, OH 44118 |
| Contact | Tatjana Zikov |
| Correspondent | Tatjana Zikov NeuroWave Systems Inc. 2490 Lee Blvd, Suite 300 Cleveland Heights, OH 44118 |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-06-23 |
| Summary: | summary |