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 |