The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Eeg-1200a Series Neurofax, Model Eeg-1200a.
| Device ID | K080546 |
| 510k Number | K080546 |
| Device Name: | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Jack Coggan |
| Correspondent | Jack Coggan NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | OLT |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-28 |
| Decision Date | 2008-08-29 |
| Summary: | summary |