The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Mee-1000a Neuromaster.
| Device ID | K051178 |
| 510k Number | K051178 |
| Device Name: | MEE-1000A NEUROMASTER |
| Classification | Stimulator, Electrical, Evoked Response |
| 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 | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-09 |
| Decision Date | 2005-08-17 |
| Summary: | summary |