FDA 510(k)

Maxcon 2加仑化疗容器

K号: K180983 · 2019-01-03

申请人Ningbo Maxcon Medical Technology Co., Ltd.

决定日期2019-01-03

产品代码MMK

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Ningbo Maxcon Medical Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K222906Maxcon 可重复使用锐器容器，17加仑锐器容器 MA1421 K222905Maxcon 锐器容器（1夸脱锐器容器，MA1112），Maxcon 锐器容器（5.4夸脱锐器容器，MA1212），Maxcon 锐器容器（5.4夸脱锐器容器，MA1213），Maxcon 锐器容器（7升锐器容器，MA1324）K180984Maxcon 锐器容器

相关器械（代码：MMK）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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