FDA 510(k)

Elvie Pump

K号: K181863 · 2018-10-10

决定日期2018-10-10

产品代码HGX

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决定实质等同

器械摘要

Elvie Pump is the device name listed in this FDA 510(k) record. The listed applicant is Chiaro Technology Limited. It received FDA 510(k) clearance on 2018-10-10 under 510(k) number K181863. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elvie Pump?

Elvie Pump is a medical device that received FDA 510(k) clearance on 2018-10-10. The listed applicant is Chiaro Technology Limited. The 510(k) number is K181863.

When did Elvie Pump receive FDA 510(k) clearance?

Elvie Pump received FDA 510(k) clearance on 2018-10-10, under 510(k) number K181863.

Who is the listed applicant for Elvie Pump?

The FDA 510(k) record lists Chiaro Technology Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elvie Pump?

The FDA product code for Elvie Pump is HGX.

列明Chiaro Technology Limited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。

K210936Elvie Stride

相关器械（代码：HGX）

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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官方来源

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