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.
Other records listing Shenzhen Med-Link Electronics Tech 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.
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Official Source
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