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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Carewell Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) 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. The listed applicant is Shenzhen Carewell Electronics Co., Ltd.. The 510(k) number is K200036.

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

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

Who is the listed applicant for AI-ECG Tracker?

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

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

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

Other records listing Shenzhen Carewell Electronics Co., 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.

K180432AI-ECG Platform

Related Devices (Code: DPS)

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.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

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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