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FDA 510(k)

Disposable Valve Sets

K-Number: K192258 · 2019-12-30

ApplicantZhejiang Chuangxiang Medical Technology Co., Ltd.
Decision Date2019-12-30
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Valve Sets is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-30 under 510(k) number K192258. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Valve Sets?

Disposable Valve Sets is a medical device that received FDA 510(k) clearance on 2019-12-30. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K192258.

When did Disposable Valve Sets receive FDA 510(k) clearance?

Disposable Valve Sets received FDA 510(k) clearance on 2019-12-30, under 510(k) number K192258.

Who is the listed applicant for Disposable Valve Sets?

The FDA 510(k) record lists Zhejiang Chuangxiang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Valve Sets?

The FDA product code for Disposable Valve Sets is ODC.

Other records listing Zhejiang Chuangxiang Medical Technology Co., Ltd. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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