The following data is part of a premarket notification filed by Suzuken Co., Ltd. with the FDA for Kenz Ecg 108 Single Channel Digital Electrocardiographs; Kenz Ecg 110 Single Channel Digital Electrocardiographs With Ec.
| Device ID | K001896 |
| 510k Number | K001896 |
| Device Name: | KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC |
| Classification | Electrocardiograph |
| Applicant | SUZUKEN CO., LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula SUZUKEN CO., LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-21 |
| Decision Date | 2001-01-08 |