FDA 510(k)

MagPro R20

K号: K160280 · 2016-05-16

决定日期2016-05-16

产品代码GWF

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决定实质等同

器械摘要

MagPro R20 is the device name listed in this FDA 510(k) record. The listed applicant is Tonica Elektronik A/S. It received FDA 510(k) clearance on 2016-05-16 under 510(k) number K160280. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MagPro R20?

MagPro R20 is a medical device that received FDA 510(k) clearance on 2016-05-16. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K160280.

When did MagPro R20 receive FDA 510(k) clearance?

MagPro R20 received FDA 510(k) clearance on 2016-05-16, under 510(k) number K160280.

Who is the listed applicant for MagPro R20?

The FDA 510(k) record lists Tonica Elektronik A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagPro R20?

The FDA product code for MagPro R20 is GWF.

列明Tonica Elektronik A/S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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