The following data is part of a premarket notification filed by Nitto Denko America, Inc. with the FDA for Electrode Rte-3, Clip-on Diagnostic Electrode.
| Device ID | K871441 |
| 510k Number | K871441 |
| Device Name: | ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | NITTO DENKO AMERICA, INC. 55 NICHOLSON LN. San Jose, CA 95134 |
| Contact | Kogami |
| Correspondent | Kogami NITTO DENKO AMERICA, INC. 55 NICHOLSON LN. San Jose, CA 95134 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-13 |
| Decision Date | 1987-08-03 |