The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Nihon Kohden Wireless Input Unit Wee-1200.
| Device ID | K171124 |
| 510k Number | K171124 |
| Device Name: | Nihon Kohden Wireless Input Unit WEE-1200 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Nihon Kohden Corporation 1-31-4 Nisahiochiai, Shinjuku-Ku Tokyo, JP 161-8560 |
| Contact | Tom Bento |
| Correspondent | Tom Bento Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, CA 92618 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-17 |
| Decision Date | 2017-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04931921903759 | K171124 | 000 |
| 04931921130377 | K171124 | 000 |
| 04931921130384 | K171124 | 000 |
| 04931921130391 | K171124 | 000 |
| 04931921130421 | K171124 | 000 |
| 04931921130445 | K171124 | 000 |
| 04931921130469 | K171124 | 000 |
| 04931921130599 | K171124 | 000 |
| 04931921130605 | K171124 | 000 |
| 04931921130612 | K171124 | 000 |
| 04931921130629 | K171124 | 000 |
| 04931921130636 | K171124 | 000 |
| 04931921130643 | K171124 | 000 |
| 04931921130964 | K171124 | 000 |
| 04931921900925 | K171124 | 000 |
| 04931921130360 | K171124 | 000 |