The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Mem-4204-4-8, Meb-4204 &4208 Evoke Potent Meas Sys.
| Device ID | K912685 |
| 510k Number | K912685 |
| Device Name: | MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Diana Beal |
| Correspondent | Diana Beal 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 | 1991-06-17 |
| Decision Date | 1992-02-26 |