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FDA 510(k)

Giftlife™受精介质；Giftlife™分裂介质；Giftlife™囊胚介质；Giftlife™单步介质

K号: K240149 · 2024-06-13

申请人Gimbo Medical Technology Shenzhen Co., Ltd.
决定日期2024-06-13
产品代码MQL
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

Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium is the device name listed in this FDA 510(k) record. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K240149. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium?

Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K240149.

When did Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium receive FDA 510(k) clearance?

Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium received FDA 510(k) clearance on 2024-06-13, under 510(k) number K240149.

Who is the listed applicant for Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium?

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

What is the FDA product code for Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium?

The FDA product code for Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium is MQL.

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Gimbo Medical Technology Shenzhen 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。

K253121Giftlife单腔卵母细胞采集针，Giftlife双腔卵母细胞采集针K242043精子冷冻介质K242968Giftlife® 单步中号加强型K240002G-Vitri™玻璃化吸管K234023卵母细胞冲洗与采集介质；配子缓冲液K232942G-Vitri™玻璃化冷冻介质；G-Vitri™玻璃化解冻介质

查看所有 7 个设备 →

相关器械（代码：MQL）

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。

K254261玻璃化冷冻试剂盒和解冻试剂盒（CS-IVF-FK；CS-IVF-TK）CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248超快速升温Kitazato CorporationK252672CaseBio® Culture w/HSA (CMH5)；CaseBio® Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin 生殖培养基（Dewin 精子缓冲液[含HSA和不含HSA]; Dewin 卵泡冲洗液，Dewin 一步法培养基[含HSA和不含HSA]）Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305超快速玻璃化；超快速温控Kitazato Corporation

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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