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FDA 510(k)

Fully Automatic Electronic Blood Pressure Monitor

K号: K160565 · 2016-08-10

决定日期2016-08-10
产品代码DXN
咨询委员会CV
决定Substantially Equivalent

器械摘要

Fully Automatic Electronic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K160565. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fully Automatic Electronic Blood Pressure Monitor?

Fully Automatic Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K160565.

When did Fully Automatic Electronic Blood Pressure Monitor receive FDA 510(k) clearance?

Fully Automatic Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2016-08-10, under 510(k) number K160565.

Who is the listed applicant for Fully Automatic Electronic Blood Pressure Monitor?

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

What is the FDA product code for Fully Automatic Electronic Blood Pressure Monitor?

The FDA product code for Fully Automatic Electronic Blood Pressure Monitor is DXN.

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列明Andon Health Co, Ltd.为申报人的其他记录

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相关器械(代码:DXN)

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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