STERIZONE VP4 消毒器
K 號：K153392 · 2016-03-24
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申請人Ts03, Inc.
決定日期2016-03-24
產品代碼PJJ
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
STERIZONE VP4 Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Ts03, Inc.. It received FDA 510(k) clearance on 2016-03-24 under 510(k) number K153392. The device is classified under product code PJJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the STERIZONE VP4 Sterilizer?
STERIZONE VP4 Sterilizer is a medical device that received FDA 510(k) clearance on 2016-03-24. The listed applicant is Ts03, Inc.. The 510(k) number is K153392.
When did STERIZONE VP4 Sterilizer receive FDA 510(k) clearance?
STERIZONE VP4 Sterilizer received FDA 510(k) clearance on 2016-03-24, under 510(k) number K153392.
Who is the listed applicant for STERIZONE VP4 Sterilizer?
The FDA 510(k) record lists Ts03, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for STERIZONE VP4 Sterilizer?
The FDA product code for STERIZONE VP4 Sterilizer is PJJ.
相關臨床試驗
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相關器械（代碼：PJJ）
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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