The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Neurofax, Model Eeg-1100a.
| Device ID | K992742 |
| 510k Number | K992742 |
| Device Name: | NEUROFAX, MODEL EEG-1100A |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Bonnie Bishop |
| Correspondent | Bonnie Bishop NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-16 |
| Decision Date | 1999-10-14 |
| Summary: | summary |