The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Electrocardiograph.
| Device ID | K813266 |
| 510k Number | K813266 |
| Device Name: | NIHON KOHDEN ELECTROCARDIOGRAPH |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | NIHON KOHDEN AMERICA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-20 |
| Decision Date | 1982-01-29 |