The following data is part of a premarket notification filed by Suzuken Co., Ltd. with the FDA for Kenz 80z Mark Ii.
| Device ID | K843731 |
| 510k Number | K843731 |
| Device Name: | KENZ 80Z MARK II |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SUZUKEN CO., LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-24 |
| Decision Date | 1985-07-11 |