FDA 510(k)

AccuSert Needle Inserter

K号: K213429 · 2022-10-20

决定日期2022-10-20

产品代码KZH

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

AccuSert Needle Inserter is the device name listed in this FDA 510(k) record. The listed applicant is Emed Technologies Corporation. It received FDA 510(k) clearance on 2022-10-20 under 510(k) number K213429. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AccuSert Needle Inserter?

AccuSert Needle Inserter is a medical device that received FDA 510(k) clearance on 2022-10-20. The listed applicant is Emed Technologies Corporation. The 510(k) number is K213429.

When did AccuSert Needle Inserter receive FDA 510(k) clearance?

AccuSert Needle Inserter received FDA 510(k) clearance on 2022-10-20, under 510(k) number K213429.

Who is the listed applicant for AccuSert Needle Inserter?

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

What is the FDA product code for AccuSert Needle Inserter?

The FDA product code for AccuSert Needle Inserter is KZH.

列明Emed Technologies Corporation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。

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官方来源

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