AI-ECG Platform

FDA 510(k) K180432 · Shenzhen Carewell Electronics., Ltd.

Substantially Equivalent

510(k) numberK180432

Submission

Device name
AI-ECG Platform
Applicant
Shenzhen Carewell Electronics., Ltd.
Shenzhen, CN
Received
February 20, 2018
Decision date
November 19, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQK – Computer, Diagnostic, Programmable
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1425
Specialty
Cardiovascular

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Questions and answers

When was AI-ECG Platform cleared by the FDA?

AI-ECG Platform (K180432) received a 510(k) decision of Substantially Equivalent on November 19, 2018, 272 days after the submission was received.

What is the product code of K180432?

The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.