FDA 510(k)

Maxcon 兩加侖化學治療容器

K 號：K180983 · 2019-01-03

申請人Ningbo Maxcon Medical Technology Co., Ltd.

決定日期2019-01-03

產品代碼MMK

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

Maxcon Two Gallon Chemotherapy Container is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Maxcon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K180983. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Maxcon Two Gallon Chemotherapy Container?

Maxcon Two Gallon Chemotherapy Container is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Ningbo Maxcon Medical Technology Co., Ltd.. The 510(k) number is K180983.

When did Maxcon Two Gallon Chemotherapy Container receive FDA 510(k) clearance?

Maxcon Two Gallon Chemotherapy Container received FDA 510(k) clearance on 2019-01-03, under 510(k) number K180983.

Who is the listed applicant for Maxcon Two Gallon Chemotherapy Container?

The FDA 510(k) record lists Ningbo Maxcon Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Maxcon Two Gallon Chemotherapy Container?

The FDA product code for Maxcon Two Gallon Chemotherapy Container is MMK.

其他以 Ningbo Maxcon Medical Technology Co., Ltd. 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。

K222906Maxcon可重用針筒容器，17加侖針筒容器 MA1421 K222905Maxcon 尖端容器（1夸脱尖端容器，MA1112），Maxcon 尖端容器（5.4夸脱尖端容器，MA1212），Maxcon 尖端容器（5.4夸脱尖端容器，MA1213），Maxcon 尖端容器（7升尖端容器，MA1324）K180984Maxcon 射線容器

相關器械（代碼：MMK）

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。

官方來源

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