The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Psg Input Box, Model Je-912ak.
| Device ID | K022121 |
| 510k Number | K022121 |
| Device Name: | PSG INPUT BOX, MODEL JE-912AK |
| 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 | 2002-07-01 |
| Decision Date | 2002-07-29 |
| Summary: | summary |