The following data is part of a premarket notification filed by Suzuken Co., Ltd. with the FDA for Kenz Cardy302 Max.
| Device ID | K101024 |
| 510k Number | K101024 |
| Device Name: | KENZ CARDY302 MAX |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | SUZUKEN CO., LTD. 1201 RICHARDSON SUITE 280 Richardson, TX 75080 |
| Contact | Linda Morgan |
| Correspondent | Linda Morgan SUZUKEN CO., LTD. 1201 RICHARDSON SUITE 280 Richardson, TX 75080 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-13 |
| Decision Date | 2011-01-06 |
| Summary: | summary |