The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Mem-7102; Meb-7102 Evoked Response & Electro Recor.
| Device ID | K890274 |
| 510k Number | K890274 |
| Device Name: | MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Kevin Morton |
| Correspondent | Kevin Morton NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-18 |
| Decision Date | 1989-05-18 |