FDA 510(k)

マックスコン・ツーガロンの化学療法容器

K番号: K180983 · 2019-01-03

申請者Ningbo Maxcon Medical Technology Co., Ltd.

決定日2019-01-03

製品コードMMK

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてNingbo Maxcon Medical Technology Co., Ltd.を記載するその他の記録

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