The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Emg Modules For Polygraph System.
| Device ID | K823562 |
| 510k Number | K823562 |
| Device Name: | EMG MODULES FOR POLYGRAPH SYSTEM |
| Classification | Electromyograph, Diagnostic |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-02 |
| Decision Date | 1983-01-14 |