Medifine Pen針筒3斜邊，Medifine Pen針筒Quinta 5斜邊
K 號：K171144 · 2017-09-12
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申請人Medbio, LLC
決定日期2017-09-12
產品代碼FMI
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel is the device name listed in this FDA 510(k) record. The listed applicant is Medbio, LLC. It received FDA 510(k) clearance on 2017-09-12 under 510(k) number K171144. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel?
Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel is a medical device that received FDA 510(k) clearance on 2017-09-12. The listed applicant is Medbio, LLC. The 510(k) number is K171144.
When did Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel receive FDA 510(k) clearance?
Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel received FDA 510(k) clearance on 2017-09-12, under 510(k) number K171144.
Who is the listed applicant for Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel?
The FDA 510(k) record lists Medbio, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel?
The FDA product code for Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel is FMI.
相關臨床試驗
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。
相關器械（代碼：FMI）
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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