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FDA 510(k)

TD-5010 刺针器和 TD-5084 无菌刺针

K号: K221419 · 2023-01-20

决定日期2023-01-20
产品代码QRL
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

TD-5010 Lancing Device and TD-5084 Sterile Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Gostar Co., Ltd.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K221419. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TD-5010 Lancing Device and TD-5084 Sterile Lancets?

TD-5010 Lancing Device and TD-5084 Sterile Lancets is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Gostar Co., Ltd.. The 510(k) number is K221419.

When did TD-5010 Lancing Device and TD-5084 Sterile Lancets receive FDA 510(k) clearance?

TD-5010 Lancing Device and TD-5084 Sterile Lancets received FDA 510(k) clearance on 2023-01-20, under 510(k) number K221419.

Who is the listed applicant for TD-5010 Lancing Device and TD-5084 Sterile Lancets?

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

What is the FDA product code for TD-5010 Lancing Device and TD-5084 Sterile Lancets?

The FDA product code for TD-5010 Lancing Device and TD-5084 Sterile Lancets is QRL.

相关临床试验

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。

列明Gostar 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。

相关器械(代码:QRL)

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。

官方来源

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