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FDA 510(k)

DORADOnova MR3T

K号: K173926 · 2018-09-14

决定日期2018-09-14
产品代码IYE
咨询委员会RA
决定实质等同

器械摘要

DORADOnova MR3T is the device name listed in this FDA 510(k) record. The listed applicant is Lap GmbH Laser Applikationen. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K173926. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DORADOnova MR3T?

DORADOnova MR3T is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Lap GmbH Laser Applikationen. The 510(k) number is K173926.

When did DORADOnova MR3T receive FDA 510(k) clearance?

DORADOnova MR3T received FDA 510(k) clearance on 2018-09-14, under 510(k) number K173926.

Who is the listed applicant for DORADOnova MR3T?

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

What is the FDA product code for DORADOnova MR3T?

The FDA product code for DORADOnova MR3T is IYE.

相关临床试验

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列明Lap GmbH Laser Applikationen为申报人的其他记录

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相关器械(代码:IYE)

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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