FDA 510(k)

CompuFlo硬脊膜電腦控制麻醉系統

K 號：K161883 · 2017-06-09

決定日期2017-06-09

產品代碼FMF

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

CompuFlo Epidural Computer Controlled Anesthesia System is the device name listed in this FDA 510(k) record. The listed applicant is Milestone Scientific, Inc.. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K161883. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CompuFlo Epidural Computer Controlled Anesthesia System?

CompuFlo Epidural Computer Controlled Anesthesia System is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Milestone Scientific, Inc.. The 510(k) number is K161883.

When did CompuFlo Epidural Computer Controlled Anesthesia System receive FDA 510(k) clearance?

CompuFlo Epidural Computer Controlled Anesthesia System received FDA 510(k) clearance on 2017-06-09, under 510(k) number K161883.

Who is the listed applicant for CompuFlo Epidural Computer Controlled Anesthesia System?

The FDA 510(k) record lists Milestone Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CompuFlo Epidural Computer Controlled Anesthesia System?

The FDA product code for CompuFlo Epidural Computer Controlled Anesthesia System is FMF.

其他以 Milestone Scientific, Inc. 為申請人之記錄

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K221702CompuFlo硬脊膜電腦控制麻醉系統

相關器械（代碼：FMF）

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

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