FDA 510(k)

MEDOJECT 细针

K号: K220614 · 2022-06-15

决定日期2022-06-15

产品代码FMI

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

MEDOJECT fine Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is Chirana T. Injecta. It received FDA 510(k) clearance on 2022-06-15 under 510(k) number K220614. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MEDOJECT fine Pen Needles?

MEDOJECT fine Pen Needles is a medical device that received FDA 510(k) clearance on 2022-06-15. The listed applicant is Chirana T. Injecta. The 510(k) number is K220614.

When did MEDOJECT fine Pen Needles receive FDA 510(k) clearance?

MEDOJECT fine Pen Needles received FDA 510(k) clearance on 2022-06-15, under 510(k) number K220614.

Who is the listed applicant for MEDOJECT fine Pen Needles?

The FDA 510(k) record lists Chirana T. Injecta as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDOJECT fine Pen Needles?

The FDA product code for MEDOJECT fine Pen Needles is FMI.

列明Chirana T. Injecta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。

K242434胰岛素注射器 K201044CHIRANA胰岛素注射器 K201009CHIRAVAC 血液采集针

相关器械（代码：FMI）

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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