The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Mem-4104 Evoked Response/electromyography Recorder.
| Device ID | K870794 |
| 510k Number | K870794 |
| Device Name: | MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER |
| Classification | Amplifier, Physiological Signal |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Cathy A Cronin |
| Correspondent | Cathy A Cronin NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-26 |
| Decision Date | 1987-09-30 |