FDA 510(k)

Avologi ENEO

K号: K181659 · 2018-07-26

决定日期2018-07-26

产品代码OHS

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决定实质等同

器械摘要

Avologi ENEO is the device name listed in this FDA 510(k) record. The listed applicant is Premier North America, Inc.. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K181659. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Avologi ENEO?

Avologi ENEO is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Premier North America, Inc.. The 510(k) number is K181659.

When did Avologi ENEO receive FDA 510(k) clearance?

Avologi ENEO received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181659.

Who is the listed applicant for Avologi ENEO?

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

What is the FDA product code for Avologi ENEO?

The FDA product code for Avologi ENEO is OHS.

列明Premier North America, 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：OHS）

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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