FDA 510(k)

Bronchi and Gastrointestinal Cytology Brush

K号: K171607 · 2017-07-31

申请人Wilson-Cook Medical Inc./Cook Endoscopy

决定日期2017-07-31

产品代码FDX

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Bronchi and Gastrointestinal Cytology Brush is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K171607. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bronchi and Gastrointestinal Cytology Brush?

Bronchi and Gastrointestinal Cytology Brush is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K171607.

When did Bronchi and Gastrointestinal Cytology Brush receive FDA 510(k) clearance?

Bronchi and Gastrointestinal Cytology Brush received FDA 510(k) clearance on 2017-07-31, under 510(k) number K171607.

Who is the listed applicant for Bronchi and Gastrointestinal Cytology Brush?

The FDA 510(k) record lists Wilson-Cook Medical Inc./Cook Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bronchi and Gastrointestinal Cytology Brush?

The FDA product code for Bronchi and Gastrointestinal Cytology Brush is FDX.

列明Wilson-Cook Medical Inc./Cook Endoscopy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。

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