SAM IO 骨內進入系統
K 號：K191488 · 2019-11-21
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決定日期2019-11-21
產品代碼FMI
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
SAM IO Intraosseous Access System is the device name listed in this FDA 510(k) record. The listed applicant is Sam® Medical Products, Inc.. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K191488. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SAM IO Intraosseous Access System?
SAM IO Intraosseous Access System is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Sam® Medical Products, Inc.. The 510(k) number is K191488.
When did SAM IO Intraosseous Access System receive FDA 510(k) clearance?
SAM IO Intraosseous Access System received FDA 510(k) clearance on 2019-11-21, under 510(k) number K191488.
Who is the listed applicant for SAM IO Intraosseous Access System?
The FDA 510(k) record lists Sam® Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SAM IO Intraosseous Access System?
The FDA product code for SAM IO Intraosseous Access System is FMI.
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相關器械（代碼：FMI）
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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