FDA 510(k)

Healy

K号: K191075 · 2019-11-22

决定日期2019-11-22

产品代码NUH

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决定实质等同

器械摘要

Healy is the device name listed in this FDA 510(k) record. The listed applicant is Timewaver Production GmbH. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K191075. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Healy?

Healy is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Timewaver Production GmbH. The 510(k) number is K191075.

When did Healy receive FDA 510(k) clearance?

Healy received FDA 510(k) clearance on 2019-11-22, under 510(k) number K191075.

Who is the listed applicant for Healy?

The FDA 510(k) record lists Timewaver Production GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healy?

The FDA product code for Healy is NUH.

列明Timewaver Production GmbH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。

K212832TimeWaver 频率

相关器械（代码：NUH）

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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