FDA 510(k)

Metapex Plus

K号: K202617 · 2021-04-14

决定日期2021-04-14

产品代码KIF

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决定实质等同

器械摘要

Metapex Plus is the device name listed in this FDA 510(k) record. The listed applicant is Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2021-04-14 under 510(k) number K202617. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Metapex Plus?

Metapex Plus is a medical device that received FDA 510(k) clearance on 2021-04-14. The listed applicant is Meta Biomed Co., Ltd.. The 510(k) number is K202617.

When did Metapex Plus receive FDA 510(k) clearance?

Metapex Plus received FDA 510(k) clearance on 2021-04-14, under 510(k) number K202617.

Who is the listed applicant for Metapex Plus?

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

What is the FDA product code for Metapex Plus?

The FDA product code for Metapex Plus is KIF.

列明Meta Biomed 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。

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