Alpha Pure
K 號：K163117 · 2017-05-09
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器材摘要
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.
常見問題
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.
相關臨床試驗
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相關器械（代碼：NJM）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
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