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FDA 510(k)

Maxcon 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）

K号: K222905 · 2023-06-01

申请人Ningbo Maxcon Medical Technology Co., Ltd.
决定日期2023-06-01
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 Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) 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 2023-06-01 under 510(k) number K222905. 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 Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)?

Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Ningbo Maxcon Medical Technology Co., Ltd.. The 510(k) number is K222905.

When did Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) receive FDA 510(k) clearance?

Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) received FDA 510(k) clearance on 2023-06-01, under 510(k) number K222905.

Who is the listed applicant for Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)?

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 Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)?

The FDA product code for Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) is MMK.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 MA1421K180983Maxcon 2加仑化疗容器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。

K260845华宏锐器容器（HHR-I，HHR-II）Tianjin Huahong Technology Co., Ltd.K253773冠红锐器容器（GHW-1F1）；冠红锐器容器（GHW-1F4）；冠红锐器容器（GH-6FA）；冠红锐器容器（GHW-2FR）；冠红锐器容器（GHW-8FR）；冠红锐器容器（GH-3FS）；冠红锐器容器（GHW-15FS）；冠红锐器容器（GHW-27FS）；冠红锐器容器（GH-5FSW）；冠红锐器容器（GHW-3FT）；冠红锐器容器（GHW-4FT）；冠红锐器容器（GHW-5FT）；冠红锐器容器（GHW-8FT）；冠红Taizhou Huangyan Guanhong Plastic Steel Products FactoryK253222公洞锐器容器（SCR-01Q，SCR-01G，SCR-03G）Zhejiang Gongdong Medical Technology Co., Ltd.K252637社区容器（翻盖和雏菊）Keter Canada, Inc.K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc.K231484PureWay 1.4 Quart Sharps CollectorPureway Compliance, Inc.

官方来源

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