The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Elefix V Paste For Eeg & Emg.
| Device ID | K191975 |
| 510k Number | K191975 |
| Device Name: | Elefix V Paste For EEG & EMG |
| Classification | Media, Electroconductive |
| Applicant | Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-ku Tokyo, JP 161-8560 |
| Contact | Sandra Gadeyne |
| Correspondent | Natalie Kennel NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-24 |
| Decision Date | 2020-02-07 |