CapKlenZ
K 號：K192382 · 2020-04-20
廣告
決定日期2020-04-20
產品代碼QBP
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
CapKlenZ is the device name listed in this FDA 510(k) record. The listed applicant is Star Mountain Medical, Inc.. It received FDA 510(k) clearance on 2020-04-20 under 510(k) number K192382. The device is classified under product code QBP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CapKlenZ?
CapKlenZ is a medical device that received FDA 510(k) clearance on 2020-04-20. The listed applicant is Star Mountain Medical, Inc.. The 510(k) number is K192382.
When did CapKlenZ receive FDA 510(k) clearance?
CapKlenZ received FDA 510(k) clearance on 2020-04-20, under 510(k) number K192382.
Who is the listed applicant for CapKlenZ?
The FDA 510(k) record lists Star Mountain Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CapKlenZ?
The FDA product code for CapKlenZ is QBP.
相關臨床試驗
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相關器械（代碼：QBP）
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。
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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