The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Model Meb-5304 Evoked Potential & Electro. Record.
| Device ID | K881177 |
| 510k Number | K881177 |
| Device Name: | MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD |
| Classification | Amplifier, Physiological Signal |
| 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 | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-18 |
| Decision Date | 1988-09-30 |