FDA 510(k)

Tetra (商標-20)；Tetra (商標-50)

K 號：K251105 · 2025-12-22

決定日期2025-12-22

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

Tetra (TM-20); Tetra (TM-50) 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 2025-12-22 under 510(k) number K251105. 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 Tetra (TM-20); Tetra (TM-50)?

Tetra (TM-20); Tetra (TM-50) is a medical device that received FDA 510(k) clearance on 2025-12-22. The listed applicant is Emed Technologies Corporation. The 510(k) number is K251105.

When did Tetra (TM-20); Tetra (TM-50) receive FDA 510(k) clearance?

Tetra (TM-20); Tetra (TM-50) received FDA 510(k) clearance on 2025-12-22, under 510(k) number K251105.

Who is the listed applicant for Tetra (TM-20); Tetra (TM-50)?

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 Tetra (TM-20); Tetra (TM-50)?

The FDA product code for Tetra (TM-20); Tetra (TM-50) 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。

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 K161906SCIg60 注射器

查看所有 7 項裝置 →

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。

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 K161906SCIg60 注射器Emed Technologies Corporation

官方來源

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