The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Neurofile Data Storage/accesories To The Eeg-4300.
| Device ID | K905594 |
| 510k Number | K905594 |
| Device Name: | NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 |
| Classification | Conditioner, Signal, Physiological |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Bill Abrams |
| Correspondent | Bill Abrams NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | GWK |
| CFR Regulation Number | 882.1845 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-13 |
| Decision Date | 1991-06-28 |