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FDA 510(k)

AI-ECG Platform

K-Number: K180432 · 2018-11-19

ApplicantShenzhen Carewell Electronics., Ltd.
Decision Date2018-11-19
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AI-ECG Platform is a medical device manufactured by Shenzhen Carewell Electronics., Ltd.. It received FDA 510(k) clearance on 2018-11-19 under approval number K180432. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI-ECG Platform?

AI-ECG Platform is a medical device that received FDA 510(k) clearance on 2018-11-19. It is manufactured by Shenzhen Carewell Electronics., Ltd.. The 510(k) number is K180432.

When was AI-ECG Platform approved by the FDA?

AI-ECG Platform received FDA 510(k) clearance on 2018-11-19, under approval number K180432.

What company makes AI-ECG Platform?

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

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

The FDA product code for AI-ECG Platform is DQK.

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Official Source

View on FDA Database →

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

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