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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changke Connect Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-03-25 under 510(k) 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. The listed applicant is Shenzhen Changke Connect Electronics Co., Ltd.. The 510(k) number is K193629.

When did Disposable NIBP Cuff receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable NIBP Cuff?

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

What is the FDA product code for Disposable NIBP Cuff?

The FDA product code for Disposable NIBP Cuff is DXQ.

Other records listing Shenzhen Changke Connect Electronics 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.

View all 8 devices →

Related Devices (Code: DXQ)

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.

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.