FDA 510(k)

Axiostat Patch

K号: K202830 · 2021-04-15

决定日期2021-04-15

产品代码QSY

决定实质等同

器械摘要

Axiostat Patch is the device name listed in this FDA 510(k) record. The listed applicant is Advamedica, Inc.. It received FDA 510(k) clearance on 2021-04-15 under 510(k) number K202830. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常见问题

What is the Axiostat Patch?

Axiostat Patch is a medical device that received FDA 510(k) clearance on 2021-04-15. The listed applicant is Advamedica, Inc.. The 510(k) number is K202830.

When did Axiostat Patch receive FDA 510(k) clearance?

Axiostat Patch received FDA 510(k) clearance on 2021-04-15, under 510(k) number K202830.

Who is the listed applicant for Axiostat Patch?

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

What is the FDA product code for Axiostat Patch?

The FDA product code for Axiostat Patch is QSY.

列明Advamedica, Inc.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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相关器械（代码：QSY）

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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