FDA 510(k)

维克坦

K号: K230593 · 2023-05-30

申请人Jiangsu Haize Medical Scientific Development Co., Ltd.

决定日期2023-05-30

产品代码GEI

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

Victan is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Haize Medical Scientific Development Co., Ltd.. It received FDA 510(k) clearance on 2023-05-30 under 510(k) number K230593. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Victan?

Victan is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is Jiangsu Haize Medical Scientific Development Co., Ltd.. The 510(k) number is K230593.

When did Victan receive FDA 510(k) clearance?

Victan received FDA 510(k) clearance on 2023-05-30, under 510(k) number K230593.

Who is the listed applicant for Victan?

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

What is the FDA product code for Victan?

The FDA product code for Victan is GEI.

列明Jiangsu Haize Medical Scientific Development 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。

K161421单次使用外科吸引冲洗器

相关器械（代码：GEI）

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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