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FDA 510(k)

Reusable NIBP Cuff

K-Number: K191253 · 2019-09-17

Decision Date2019-09-17
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reusable NIBP Cuff is a medical device manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-09-17 under approval number K191253. 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 Reusable NIBP Cuff?

Reusable NIBP Cuff is a medical device that received FDA 510(k) clearance on 2019-09-17. It is manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. The 510(k) number is K191253.

When was Reusable NIBP Cuff approved by the FDA?

Reusable NIBP Cuff received FDA 510(k) clearance on 2019-09-17, under approval number K191253.

What company makes Reusable NIBP Cuff?

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

What is the FDA product code for Reusable NIBP Cuff?

The FDA product code for Reusable 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.