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FDA 510(k)

Disposable NIBP Cuff

K-Number: K193629 · 2020-03-25

Decision Date2020-03-25
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable NIBP Cuff is a medical device manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-03-25 under approval number K193629. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable NIBP Cuff?

Disposable NIBP Cuff is a medical device that received FDA 510(k) clearance on 2020-03-25. It is manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. The 510(k) number is K193629.

When was Disposable NIBP Cuff approved by the FDA?

Disposable NIBP Cuff received FDA 510(k) clearance on 2020-03-25, under approval number K193629.

What company makes Disposable NIBP Cuff?

Disposable NIBP Cuff is manufactured by Shenzhen Changke Connect Electronics Co., Ltd..

What is the FDA product code for Disposable NIBP Cuff?

The FDA product code for Disposable NIBP Cuff is DXQ.

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

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Related Devices (Code: DXQ)

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.