The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Model Rm 6000, 6100,6200 Polygraph.
| Device ID | K823281 |
| 510k Number | K823281 |
| Device Name: | MODEL RM 6000, 6100,6200 POLYGRAPH |
| Classification | Electrocardiograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-03 |
| Decision Date | 1982-12-22 |