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FDA 510(k)

BEXCORE Breast Biopsy System, Biopsy Needle

K号: K171890 · 2018-08-20

申请人Medical Park Co., Ltd.
决定日期2018-08-20
产品代码KNW
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

BEXCORE Breast Biopsy System, Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Medical Park Co., Ltd.. It received FDA 510(k) clearance on 2018-08-20 under 510(k) number K171890. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BEXCORE Breast Biopsy System, Biopsy Needle?

BEXCORE Breast Biopsy System, Biopsy Needle is a medical device that received FDA 510(k) clearance on 2018-08-20. The listed applicant is Medical Park Co., Ltd.. The 510(k) number is K171890.

When did BEXCORE Breast Biopsy System, Biopsy Needle receive FDA 510(k) clearance?

BEXCORE Breast Biopsy System, Biopsy Needle received FDA 510(k) clearance on 2018-08-20, under 510(k) number K171890.

Who is the listed applicant for BEXCORE Breast Biopsy System, Biopsy Needle?

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

What is the FDA product code for BEXCORE Breast Biopsy System, Biopsy Needle?

The FDA product code for BEXCORE Breast Biopsy System, Biopsy Needle is KNW.

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相关器械（代码：KNW）

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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