信娜針筒；信娜安全針筒
K 號：K231165 · 2023-10-27
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決定日期2023-10-27
產品代碼MEG
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
Shina Syringe; Shina Safety Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Shina Med Corporation. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K231165. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Shina Syringe; Shina Safety Syringe?
Shina Syringe; Shina Safety Syringe is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Shina Med Corporation. The 510(k) number is K231165.
When did Shina Syringe; Shina Safety Syringe receive FDA 510(k) clearance?
Shina Syringe; Shina Safety Syringe received FDA 510(k) clearance on 2023-10-27, under 510(k) number K231165.
Who is the listed applicant for Shina Syringe; Shina Safety Syringe?
The FDA 510(k) record lists Shina Med Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Shina Syringe; Shina Safety Syringe?
The FDA product code for Shina Syringe; Shina Safety Syringe is MEG.
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。
其他以 Shina Med Corporation 為申請人之記錄
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：MEG）
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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