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FDA 510(k)

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

K号: K232493 · 2024-05-07

申请人Wuhan Huchuang Union Technology Co., Ltd.
决定日期2024-05-07
产品代码MQG
咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Huchuang Union Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K232493. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Wuhan Huchuang Union Technology Co., Ltd.. The 510(k) number is K232493.

When did Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) receive FDA 510(k) clearance?

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) received FDA 510(k) clearance on 2024-05-07, under 510(k) number K232493.

Who is the listed applicant for Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

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

What is the FDA product code for Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

The FDA product code for Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is MQG.

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

相关器械（代码：MQG）

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。

K261083华莱士® 吸引泵（WAPV1）；华莱士® 泵过滤器连接器（WFC）；华莱士® 真空连接套件（WVCK）CooperSurgical, Inc.K260194真空泵（型号：AD-VPUM-500）Sheng Sheng Yi (Beijing) Technology Company LimitedK242684Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.K180188Geri 胚胎孵化器，配备 Geri Connect 和 Geri 评估软件，以及 Geri 碗Genea Biomedx Pty, Ltd.K173264EmbryoScope+Vitrolife A/SK180304Geri 胚胎孵化器和 Geri 碗Genea Biomedx Pty, Ltd.

官方来源

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