The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Eeg & Respiration Modules Polygraph.
| Device ID | K823563 |
| 510k Number | K823563 |
| Device Name: | EEG & RESPIRATION MODULES POLYGRAPH |
| Classification | Monitor, Breathing Frequency |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-02 |
| Decision Date | 1983-01-12 |