The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Eeg-1100a Switch Box.
| Device ID | K073491 |
| 510k Number | K073491 |
| Device Name: | EEG-1100A SWITCH BOX |
| Classification | Standard Polysomnograph With Electroencephalograph |
| 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 | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-12 |
| Decision Date | 2008-01-11 |
| Summary: | summary |