The following data is part of a premarket notification filed by Suzuken Co., Ltd. with the FDA for Kenl-ecg-3.
| Device ID | K811949 |
| 510k Number | K811949 |
| Device Name: | KENL-ECG-3 |
| Classification | Electrocardiograph |
| Applicant | SUZUKEN CO., LTD. 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 | 1981-07-07 |
| Decision Date | 1981-08-13 |