FDA 510(k)

GenNarino

K号: K160799 · 2017-02-17

决定日期2017-02-17

产品代码LTF

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决定实质等同

器械摘要

GenNarino is the device name listed in this FDA 510(k) record. The listed applicant is Saliwell , Ltd.. It received FDA 510(k) clearance on 2017-02-17 under 510(k) number K160799. The device is classified under product code LTF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GenNarino?

GenNarino is a medical device that received FDA 510(k) clearance on 2017-02-17. The listed applicant is Saliwell , Ltd.. The 510(k) number is K160799.

When did GenNarino receive FDA 510(k) clearance?

GenNarino received FDA 510(k) clearance on 2017-02-17, under 510(k) number K160799.

Who is the listed applicant for GenNarino?

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

What is the FDA product code for GenNarino?

The FDA product code for GenNarino is LTF.

列明Saliwell , Ltd.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。

K232063SaliPen K220618SaliPen K180838SaliPen

官方来源

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