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FDA 510(k)

Neoss 个人假肢

K号: K211396 · 2022-05-17

申请人Neoss, Ltd.
决定日期2022-05-17
产品代码NHA
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决定实质等同

器械摘要

Neoss Individual Prosthetics is the device name listed in this FDA 510(k) record. The listed applicant is Neoss, Ltd.. It received FDA 510(k) clearance on 2022-05-17 under 510(k) number K211396. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Neoss Individual Prosthetics?

Neoss Individual Prosthetics is a medical device that received FDA 510(k) clearance on 2022-05-17. The listed applicant is Neoss, Ltd.. The 510(k) number is K211396.

When did Neoss Individual Prosthetics receive FDA 510(k) clearance?

Neoss Individual Prosthetics received FDA 510(k) clearance on 2022-05-17, under 510(k) number K211396.

Who is the listed applicant for Neoss Individual Prosthetics?

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

What is the FDA product code for Neoss Individual Prosthetics?

The FDA product code for Neoss Individual Prosthetics is NHA.

相关临床试验

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。

相关器械(代码:NHA)

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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