The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Ae-120a Eeg Head Set.
| Device ID | K183529 |
| 510k Number | K183529 |
| Device Name: | AE-120A EEG Head Set |
| Classification | Reduced- Montage Standard Electroencephalograph |
| Applicant | Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-ku Tokyo, JP 161-8560 |
| Contact | Tom Bento |
| Correspondent | Natalie Kennel NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 |
| Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-19 |
| Decision Date | 2019-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14931921903053 | K183529 | 000 |
| 14931921903046 | K183529 | 000 |
| 04931921129975 | K183529 | 000 |
| 04931921903582 | K183529 | 000 |
| 04931921903278 | K183529 | 000 |
| 00841983104275 | K183529 | 000 |
| 00841983104282 | K183529 | 000 |