FDA 510(k)

Mallya注射笔适配器（Mallya® for Solostar®）

K号: K222689 · 2022-12-05

决定日期2022-12-05

产品代码QOG

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

Mallya Injection Pen Adapter (Mallya® for Solostar®) is the device name listed in this FDA 510(k) record. The listed applicant is Biocorp Production. It received FDA 510(k) clearance on 2022-12-05 under 510(k) number K222689. The device is classified under product code QOG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mallya Injection Pen Adapter (Mallya® for Solostar®)?

Mallya Injection Pen Adapter (Mallya® for Solostar®) is a medical device that received FDA 510(k) clearance on 2022-12-05. The listed applicant is Biocorp Production. The 510(k) number is K222689.

When did Mallya Injection Pen Adapter (Mallya® for Solostar®) receive FDA 510(k) clearance?

Mallya Injection Pen Adapter (Mallya® for Solostar®) received FDA 510(k) clearance on 2022-12-05, under 510(k) number K222689.

Who is the listed applicant for Mallya Injection Pen Adapter (Mallya® for Solostar®)?

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

What is the FDA product code for Mallya Injection Pen Adapter (Mallya® for Solostar®)?

The FDA product code for Mallya Injection Pen Adapter (Mallya® for Solostar®) is QOG.

列明Biocorp Production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。

K251500MallyaG注射笔适配器（MallyaG）K250555MallyaD注射笔适配器（MallyaD）K231820SoloSmart 注射笔适配器 (SoloSmart®)

官方来源

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