Alpha Pure
K号: K163117 · 2017-05-09
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决定日期2017-05-09
产品代码NJM
咨询委员会DE
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决定实质等同
器械摘要
Alpha Pure is the device name listed in this FDA 510(k) record. The listed applicant is Koroad America. It received FDA 510(k) clearance on 2017-05-09 under 510(k) number K163117. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Alpha Pure?
Alpha Pure is a medical device that received FDA 510(k) clearance on 2017-05-09. The listed applicant is Koroad America. The 510(k) number is K163117.
When did Alpha Pure receive FDA 510(k) clearance?
Alpha Pure received FDA 510(k) clearance on 2017-05-09, under 510(k) number K163117.
Who is the listed applicant for Alpha Pure?
The FDA 510(k) record lists Koroad America as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Alpha Pure?
The FDA product code for Alpha Pure is NJM.
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相关器械（代码：NJM）
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官方来源
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