The following data is part of a premarket notification filed by Suzuken Co.,ltd. with the FDA for Kenz Cardico1211.
| Device ID | K172068 |
| 510k Number | K172068 |
| Device Name: | Kenz Cardico1211 |
| Classification | Electrocardiograph |
| Applicant | Suzuken Co.,Ltd. 8 Higashikataha-machi, Higashi-ku Nagoya, JP 461-0015 |
| Contact | Eiji Yamaguchi |
| Correspondent | Rhona Shanker Z&B Enterprises, Inc. 12154 Darnestown Rd. #236 Gaithersburg, MD 20878 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-07 |
| Decision Date | 2018-06-01 |
| Summary: | summary |