The following data is part of a premarket notification filed by Nihon Kohden Corp. with the FDA for Ms-120bk Electric Stimulator (extension Unit).
| Device ID | K110410 |
| 510k Number | K110410 |
| Device Name: | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) |
| Classification | Electrode, Cortical |
| 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 | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-08-04 |
| Summary: | summary |