FDA 510(k)

APA 氧气刀

K号: K191602 · 2019-08-02

决定日期2019-08-02

产品代码CCW

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决定实质等同

器械摘要

APA Oxy Blade is the device name listed in this FDA 510(k) record. The listed applicant is Venner Medical (Singapore) Pte, Ltd.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K191602. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the APA Oxy Blade?

APA Oxy Blade is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Venner Medical (Singapore) Pte, Ltd.. The 510(k) number is K191602.

When did APA Oxy Blade receive FDA 510(k) clearance?

APA Oxy Blade received FDA 510(k) clearance on 2019-08-02, under 510(k) number K191602.

Who is the listed applicant for APA Oxy Blade?

The FDA 510(k) record lists Venner Medical (Singapore) Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APA Oxy Blade?

The FDA product code for APA Oxy Blade is CCW.

列明Venner Medical (Singapore) Pte, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K192511Venner PneuX™ TT（气管切开管）尺寸7.0毫米，Venner PneuX™ TT（气管切开管）尺寸8.0毫米，Venner PneuX™ TT（气管切开管）尺寸9.0毫米 K192120Venner PneuX™ ETT（气管插管）6 mm，Venner PneuX™ ETT（气管插管）7 mm，Venner PneuX™ ETT（气管插管）8 mm，Venner PneuX™ ETT（气管插管）9 mm

官方来源

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