The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Nihon Kohden Qp-160ak Eeg Trend Program.
| Device ID | K163644 |
| 510k Number | K163644 |
| Device Name: | Nihon Kohden QP-160AK EEG Trend Program |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-Ku Tokyo, JP 161-8560 |
| Contact | Tom Bento |
| Correspondent | Tom Bento Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, CA 92618 |
| Product Code | OMA |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMB |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-23 |
| Decision Date | 2017-05-19 |
| Summary: | summary |