The following data is part of a premarket notification filed by Nihon Kohden Corp. with the FDA for Psg-1100 Sleep Diagnostic System.
| Device ID | K120888 |
| 510k Number | K120888 |
| Device Name: | PSG-1100 SLEEP DIAGNOSTIC SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | NIHON KOHDEN CORP. 90 ICON STREET Foothill Ranch, CA 92610 |
| Contact | Steve Geerdes |
| Correspondent | Steve Geerdes NIHON KOHDEN CORP. 90 ICON STREET Foothill Ranch, CA 92610 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-23 |
| Decision Date | 2012-11-09 |
| Summary: | summary |