The following data is part of a premarket notification filed by Suzuken Co., Ltd. with the FDA for Disposal Ecg Electrodes, Model Easyrode.
| Device ID | K092389 |
| 510k Number | K092389 |
| Device Name: | DISPOSAL ECG ELECTRODES, MODEL EASYRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | SUZUKEN CO., LTD. 3F, 2-17-6 AKEBONO-CHO Tachikawa-shi, Tokyo, JP 190-0012 |
| Contact | Koji Kubo |
| Correspondent | Koji Kubo SUZUKEN CO., LTD. 3F, 2-17-6 AKEBONO-CHO Tachikawa-shi, Tokyo, JP 190-0012 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2009-10-13 |
| Summary: | summary |