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FDA 510(k)

Disposable ECG Cable

K-Number: K200026 · 2020-05-12

Decision Date2020-05-12
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable ECG Cable is a medical device manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-05-12 under approval number K200026. 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 Disposable ECG Cable?

Disposable ECG Cable is a medical device that received FDA 510(k) clearance on 2020-05-12. It is manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. The 510(k) number is K200026.

When was Disposable ECG Cable approved by the FDA?

Disposable ECG Cable received FDA 510(k) clearance on 2020-05-12, under approval number K200026.

What company makes Disposable ECG Cable?

Disposable ECG Cable is manufactured by Shenzhen Changke Connect Electronics Co., Ltd..

What is the FDA product code for Disposable ECG Cable?

The FDA product code for Disposable ECG Cable is DSA.

Other Devices by Shenzhen Changke Connect Electronics Co., Ltd.

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Related Devices (Code: DSA)

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.