FDA 510(k)

SCIg60 注射器

K 號：K161906 · 2016-12-01

決定日期2016-12-01

產品代碼PKP

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

SCIg60 Infuser is the device name listed in this FDA 510(k) record. The listed applicant is Emed Technologies Corporation. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K161906. The device is classified under product code PKP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SCIg60 Infuser?

SCIg60 Infuser is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Emed Technologies Corporation. The 510(k) number is K161906.

When did SCIg60 Infuser receive FDA 510(k) clearance?

SCIg60 Infuser received FDA 510(k) clearance on 2016-12-01, under 510(k) number K161906.

Who is the listed applicant for SCIg60 Infuser?

The FDA 510(k) record lists Emed Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCIg60 Infuser?

The FDA product code for SCIg60 Infuser is PKP.

其他以 Emed Technologies Corporation 為申請人之記錄

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。

K251105Tetra (商標-20)；Tetra (商標-50)K240148SCIg60 靜脈輸注系統 K230883VersaPump 渗透系統 K213429AccuSert Needle Inserter K222087SCIg60 靜脈輸注系統 K173783SCIg60 靜脈輸注系統

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相關器械（代碼：PKP）

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。

K251105Tetra (商標-20)；Tetra (商標-50)Emed Technologies Corporation K240148SCIg60 靜脈輸注系統Emed Technologies Corporation K230883VersaPump 渗透系統Emed Technologies Corporation K222087SCIg60 靜脈輸注系統Emed Technologies Corporation K173783SCIg60 靜脈輸注系統Emed Technologies Corporation

官方來源

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