FDA 510(k)

AI-ECG Platform

Número K: K180432 · 2018-11-19

RequerenteShenzhen Carewell Electronics., Ltd.

Data da decisão2018-11-19

Código do produtoDQK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

What is the AI-ECG Platform?

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

When did AI-ECG Platform receive FDA 510(k) clearance?

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

Who is the listed applicant for AI-ECG Platform?

The FDA 510(k) record lists Shenzhen Carewell Electronics., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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