FDA 510(k)

Sungshim Insulin Pen Needle

K号: K152334 · 2016-03-17

决定日期2016-03-17

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

Sungshim Insulin Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Sung Shim Medicare Co., Ltd.. It received FDA 510(k) clearance on 2016-03-17 under 510(k) number K152334. 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 Sungshim Insulin Pen Needle?

Sungshim Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Sung Shim Medicare Co., Ltd.. The 510(k) number is K152334.

When did Sungshim Insulin Pen Needle receive FDA 510(k) clearance?

Sungshim Insulin Pen Needle received FDA 510(k) clearance on 2016-03-17, under 510(k) number K152334.

Who is the listed applicant for Sungshim Insulin Pen Needle?

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

What is the FDA product code for Sungshim Insulin Pen Needle?

The FDA product code for Sungshim Insulin Pen Needle is FMI.

列明Sung Shim Medicare 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。

K152803SUNGSHIM 一次性无菌胰岛素注射器

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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