OnSite-IV
K 號：K161800 · 2016-12-06
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申請人Pharmc, LLC
決定日期2016-12-06
產品代碼LHI
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-IV is the device name listed in this FDA 510(k) record. The listed applicant is Pharmc, LLC. It received FDA 510(k) clearance on 2016-12-06 under 510(k) number K161800. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OnSite-IV?
OnSite-IV is a medical device that received FDA 510(k) clearance on 2016-12-06. The listed applicant is Pharmc, LLC. The 510(k) number is K161800.
When did OnSite-IV receive FDA 510(k) clearance?
OnSite-IV received FDA 510(k) clearance on 2016-12-06, under 510(k) number K161800.
Who is the listed applicant for OnSite-IV?
The FDA 510(k) record lists Pharmc, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OnSite-IV?
The FDA product code for OnSite-IV is LHI.
相關臨床試驗
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相關器械（代碼：LHI）
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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