UltiCare 一次性針筒
K 號：K213407 · 2021-12-16
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決定日期2021-12-16
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
UltiCare Disposable Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is Ultimed Incorporated. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K213407. 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 UltiCare Disposable Pen Needles?
UltiCare Disposable Pen Needles is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Ultimed Incorporated. The 510(k) number is K213407.
When did UltiCare Disposable Pen Needles receive FDA 510(k) clearance?
UltiCare Disposable Pen Needles received FDA 510(k) clearance on 2021-12-16, under 510(k) number K213407.
Who is the listed applicant for UltiCare Disposable Pen Needles?
The FDA 510(k) record lists Ultimed Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UltiCare Disposable Pen Needles?
The FDA product code for UltiCare Disposable Pen Needles 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
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