即時廢棄針具容器
K 號：K182235 · 2019-05-20
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決定日期2019-05-20
產品代碼MMK
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
OnSite Waste Sharps Container is the device name listed in this FDA 510(k) record. The listed applicant is Bluestone Medical, Inc.. It received FDA 510(k) clearance on 2019-05-20 under 510(k) number K182235. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OnSite Waste Sharps Container?
OnSite Waste Sharps Container is a medical device that received FDA 510(k) clearance on 2019-05-20. The listed applicant is Bluestone Medical, Inc.. The 510(k) number is K182235.
When did OnSite Waste Sharps Container receive FDA 510(k) clearance?
OnSite Waste Sharps Container received FDA 510(k) clearance on 2019-05-20, under 510(k) number K182235.
Who is the listed applicant for OnSite Waste Sharps Container?
The FDA 510(k) record lists Bluestone Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OnSite Waste Sharps Container?
The FDA product code for OnSite Waste Sharps Container is MMK.
相關臨床試驗
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相關器械（代碼：MMK）
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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