FDA 510(k)

外科隔离服

K号: K171535 · 2018-02-15

申请人Jingzhou Haixin Green Cross Medical Products Co., Ltd.

决定日期2018-02-15

产品代码FYC

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

SURGICAL ISOLATION GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Jingzhou Haixin Green Cross Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2018-02-15 under 510(k) number K171535. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SURGICAL ISOLATION GOWN?

SURGICAL ISOLATION GOWN is a medical device that received FDA 510(k) clearance on 2018-02-15. The listed applicant is Jingzhou Haixin Green Cross Medical Products Co., Ltd.. The 510(k) number is K171535.

When did SURGICAL ISOLATION GOWN receive FDA 510(k) clearance?

SURGICAL ISOLATION GOWN received FDA 510(k) clearance on 2018-02-15, under 510(k) number K171535.

Who is the listed applicant for SURGICAL ISOLATION GOWN?

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

What is the FDA product code for SURGICAL ISOLATION GOWN?

The FDA product code for SURGICAL ISOLATION GOWN is FYC.

列明Jingzhou Haixin Green Cross Medical Products Co., 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。

K222266外科口罩（GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80）

相关器械（代码：FYC）

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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官方来源

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