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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 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.

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. 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.

Other records listing Shenzhen Carewell Electronics., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200036AI-ECG Tracker

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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