The following data is part of a premarket notification filed by Nihon Kohden Corp. with the FDA for Pe-210ak Switch Box.
| Device ID | K110376 |
| 510k Number | K110376 |
| Device Name: | PE-210AK SWITCH BOX |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-09 |
| Decision Date | 2011-07-29 |
| Summary: | summary |