胃淨通
K 號：K180605 · 2018-10-24
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器材摘要
GastroFlush is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corporation. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K180605. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the GastroFlush?
GastroFlush is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Bionix Development Corporation. The 510(k) number is K180605.
When did GastroFlush receive FDA 510(k) clearance?
GastroFlush received FDA 510(k) clearance on 2018-10-24, under 510(k) number K180605.
Who is the listed applicant for GastroFlush?
The FDA 510(k) record lists Bionix Development Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GastroFlush?
The FDA product code for GastroFlush is KNT.
相關臨床試驗
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相關器械（代碼：KNT）
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。
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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