The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Neurofax, Models Eeg-1100a, Eeg-9100a.
| Device ID | K011204 |
| 510k Number | K011204 |
| Device Name: | NEUROFAX, MODELS EEG-1100A, EEG-9100A |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Bonnie Bishop |
| Correspondent | Bonnie Bishop NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2001-05-08 |