FDA 510(k)

Andorate Universal Endoscope Tip Guard

K号: K202838 · 2021-03-05

决定日期2021-03-05

产品代码OCU

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

Andorate Universal Endoscope Tip Guard is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K202838. The device is classified under product code OCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Andorate Universal Endoscope Tip Guard?

Andorate Universal Endoscope Tip Guard is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Ga Health Company Limited. The 510(k) number is K202838.

When did Andorate Universal Endoscope Tip Guard receive FDA 510(k) clearance?

Andorate Universal Endoscope Tip Guard received FDA 510(k) clearance on 2021-03-05, under 510(k) number K202838.

Who is the listed applicant for Andorate Universal Endoscope Tip Guard?

The FDA 510(k) record lists Ga Health Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Andorate Universal Endoscope Tip Guard?

The FDA product code for Andorate Universal Endoscope Tip Guard is OCU.

列明Ga Health Company Limited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。

K232118ANDORATE® 阀门套件 K231602Protego 空气水连接器；Protego 空气水瓶管；Protego 混合管 K230932ANDORATE® 阀门套件 K230280ANDORATE® 吸引阀和ANDORATE® 活检阀 K223171AquaPulse® 灌洗软管 K213095安道瑞吸阀，安道瑞气/水阀

查看所有 12 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。