CheckMyHeart Plus

Electrocardiograph

DailyCare Biomedical, Inc

The following data is part of a premarket notification filed by Dailycare Biomedical, Inc with the FDA for Checkmyheart Plus.

Pre-market Notification Details

Device IDK172778
510k NumberK172778
Device Name:CheckMyHeart Plus
ClassificationElectrocardiograph
Applicant DailyCare Biomedical, Inc 7f, No. 1, Ding-An Rd, Zhongli Dist. Taoyuan City Taoyuan,  TW 320
ContactMing Da Lee
CorrespondentMing Da Lee
DailyCare Biomedical, Inc 7f, No. 1, Ding-An Rd, Zhongli Dist. Taoyuan City Taoyuan,  TW 320
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-14
Decision Date2018-07-05
Summary:summary

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