The following data is part of a premarket notification filed by Mitsar Co., Ltd with the FDA for Mitsar-eeg.
| Device ID | K143233 |
| 510k Number | K143233 |
| Device Name: | Mitsar-EEG |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | MITSAR CO., LTD Novorossiyskaya Str. 21-2 St. Petersburg, RU 194021 |
| Contact | Semchenkov Ales |
| Correspondent | Leslie Sherlin Nova Tech EEG 8503 E. Keats Avenue Mesa, AZ 85209 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-10 |
| Decision Date | 2015-08-13 |
| Summary: | summary |