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FDA 510(k)

A-Oss

K号: K151542 · 2016-08-03

申请人Hiossen, Inc.
决定日期2016-08-03
产品代码NPM
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决定实质等同

器械摘要

A-Oss is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2016-08-03 under 510(k) number K151542. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the A-Oss?

A-Oss is a medical device that received FDA 510(k) clearance on 2016-08-03. The listed applicant is Hiossen, Inc.. The 510(k) number is K151542.

When did A-Oss receive FDA 510(k) clearance?

A-Oss received FDA 510(k) clearance on 2016-08-03, under 510(k) number K151542.

Who is the listed applicant for A-Oss?

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

What is the FDA product code for A-Oss?

The FDA product code for A-Oss is NPM.

列明Hiossen, 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:NPM)

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。

官方来源

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