自給式生物指示標
K 號：K200970 · 2020-12-28
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決定日期2020-12-28
產品代碼FRC
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
Self-Contained Biological Indicator is the device name listed in this FDA 510(k) record. The listed applicant is True Indicating, LLC. It received FDA 510(k) clearance on 2020-12-28 under 510(k) number K200970. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Self-Contained Biological Indicator?
Self-Contained Biological Indicator is a medical device that received FDA 510(k) clearance on 2020-12-28. The listed applicant is True Indicating, LLC. The 510(k) number is K200970.
When did Self-Contained Biological Indicator receive FDA 510(k) clearance?
Self-Contained Biological Indicator received FDA 510(k) clearance on 2020-12-28, under 510(k) number K200970.
Who is the listed applicant for Self-Contained Biological Indicator?
The FDA 510(k) record lists True Indicating, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Self-Contained Biological Indicator?
The FDA product code for Self-Contained Biological Indicator is FRC.
相關臨床試驗
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其他以 True Indicating, LLC 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：FRC）
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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