The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Wireless Input Unit, Model Wee-1000a Series.
| Device ID | K033475 |
| 510k Number | K033475 |
| Device Name: | WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Serrah Namini |
| Correspondent | Serrah Namini 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-03 |
| Decision Date | 2004-01-07 |
| Summary: | summary |