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FDA 510(k)

Med-link Disposable ECG Cable and Leadwires

K-Number: K220447 · 2022-06-28

ApplicantShenzhen Med-Link Electronics Tech Co., Ltd.
Decision Date2022-06-28
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Med-link Disposable ECG Cable and Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-06-28 under 510(k) number K220447. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Med-link Disposable ECG Cable and Leadwires?

Med-link Disposable ECG Cable and Leadwires is a medical device that received FDA 510(k) clearance on 2022-06-28. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K220447.

When did Med-link Disposable ECG Cable and Leadwires receive FDA 510(k) clearance?

Med-link Disposable ECG Cable and Leadwires received FDA 510(k) clearance on 2022-06-28, under 510(k) number K220447.

Who is the listed applicant for Med-link Disposable ECG Cable and Leadwires?

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

What is the FDA product code for Med-link Disposable ECG Cable and Leadwires?

The FDA product code for Med-link Disposable ECG Cable and Leadwires is DSA.

Related Clinical Trials

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Other records listing Shenzhen Med-Link Electronics Tech Co., Ltd. as applicant

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Related Devices (Code: DSA)

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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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