AI-ECG Tracker

Electrocardiograph

Shenzhen Carewell Electronics Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Carewell Electronics Co., Ltd. with the FDA for Ai-ecg Tracker.

Pre-market Notification Details

Device IDK200036
510k NumberK200036
Device Name:AI-ECG Tracker
ClassificationElectrocardiograph
Applicant Shenzhen Carewell Electronics Co., Ltd. Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park Songbai Road, Xili Street Shenzhen,  CN 518108
ContactChang Liu
CorrespondentArthur Goddard
FDA Regulatory And Quality Systems Consultant 31853 Cedar Road Mayfield Heights,  OH  44124 -4445
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-08
Decision Date2020-03-20

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