FDA 510(k)

外科手术服，型号：surgical gown-hp-3

K号: K210355 · 2021-12-16

申请人Weihai Dishang Medical Technology Co., Ltd.

决定日期2021-12-16

产品代码FYA

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 Gown, Model: surgical gown-hp-3 is the device name listed in this FDA 510(k) record. The listed applicant is Weihai Dishang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K210355. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Surgical Gown, Model: surgical gown-hp-3?

Surgical Gown, Model: surgical gown-hp-3 is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Weihai Dishang Medical Technology Co., Ltd.. The 510(k) number is K210355.

When did Surgical Gown, Model: surgical gown-hp-3 receive FDA 510(k) clearance?

Surgical Gown, Model: surgical gown-hp-3 received FDA 510(k) clearance on 2021-12-16, under 510(k) number K210355.

Who is the listed applicant for Surgical Gown, Model: surgical gown-hp-3?

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

What is the FDA product code for Surgical Gown, Model: surgical gown-hp-3?

The FDA product code for Surgical Gown, Model: surgical gown-hp-3 is FYA.

列明Weihai Dishang Medical Technology 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。

K210348一次性医用外科口罩

相关器械（代码：FYA）

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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