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FDA 510(k)

IonoStar Plus

K号: K160774 · 2016-08-03

申请人Voco GmbH
决定日期2016-08-03
产品代码EMA
咨询委员会DE
决定Substantially Equivalent

器械摘要

IonoStar Plus is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2016-08-03 under 510(k) number K160774. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IonoStar Plus?

IonoStar Plus is a medical device that received FDA 510(k) clearance on 2016-08-03. The listed applicant is Voco GmbH. The 510(k) number is K160774.

When did IonoStar Plus receive FDA 510(k) clearance?

IonoStar Plus received FDA 510(k) clearance on 2016-08-03, under 510(k) number K160774.

Who is the listed applicant for IonoStar Plus?

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

What is the FDA product code for IonoStar Plus?

The FDA product code for IonoStar Plus is EMA.

相关临床试验

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列明Voco GmbH为申报人的其他记录

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相关器械(代码:EMA)

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官方来源

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