The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Electrode Junction Box, Model Je-921a.
| Device ID | K050833 |
| 510k Number | K050833 |
| Device Name: | ELECTRODE JUNCTION BOX, MODEL JE-921A |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-01 |
| Decision Date | 2005-04-29 |
| Summary: | summary |