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FDA 510(k)

AI-ECG Tracker

K-Number: K200036 · 2020-03-20

ApplicantShenzhen Carewell Electronics Co., Ltd.
Decision Date2020-03-20
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AI-ECG Tracker is a medical device manufactured by Shenzhen Carewell Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-03-20 under approval number K200036. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI-ECG Tracker?

AI-ECG Tracker is a medical device that received FDA 510(k) clearance on 2020-03-20. It is manufactured by Shenzhen Carewell Electronics Co., Ltd.. The 510(k) number is K200036.

When was AI-ECG Tracker approved by the FDA?

AI-ECG Tracker received FDA 510(k) clearance on 2020-03-20, under approval number K200036.

What company makes AI-ECG Tracker?

AI-ECG Tracker is manufactured by Shenzhen Carewell Electronics Co., Ltd..

What is the FDA product code for AI-ECG Tracker?

The FDA product code for AI-ECG Tracker is DPS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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