PORT-X IV
K 號：K172810 · 2018-03-07
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器材摘要
PORT-X IV is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2018-03-07 under 510(k) number K172810. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PORT-X IV?
PORT-X IV is a medical device that received FDA 510(k) clearance on 2018-03-07. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K172810.
When did PORT-X IV receive FDA 510(k) clearance?
PORT-X IV received FDA 510(k) clearance on 2018-03-07, under 510(k) number K172810.
Who is the listed applicant for PORT-X IV?
The FDA 510(k) record lists Genoray Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PORT-X IV?
The FDA product code for PORT-X IV is EHD.
其他以 Genoray Co., Ltd. 為申請人之記錄
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相關器械（代碼：EHD）
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
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