The following data is part of a premarket notification filed by Suzuken Co., Ltd. with the FDA for Kenz-ecg-102 Single Channel Electrocardiograph.
| Device ID | K862544 |
| 510k Number | K862544 |
| Device Name: | KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | SUZUKEN CO., LTD. U.S.A. LIAISON OFFICE P.O. BOX 41494 Indianapolis, IN 46241 |
| Contact | Richard L Wagner |
| Correspondent | Richard L Wagner SUZUKEN CO., LTD. U.S.A. LIAISON OFFICE P.O. BOX 41494 Indianapolis, IN 46241 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-03 |
| Decision Date | 1986-08-06 |