The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Ae-800pa Eeg Module.
| Device ID | K884537 |
| 510k Number | K884537 |
| Device Name: | AE-800PA EEG MODULE |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Mike Dashefsky |
| Correspondent | Mike Dashefsky NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-28 |
| Decision Date | 1988-12-29 |