FDA 510(k)

Giftlife® 单步中号加强型

K号: K242968 · 2024-11-22

申请人Gimbo Medical Technology Shenzhen Co., Ltd.

决定日期2024-11-22

产品代码MQL

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决定实质等同

器械摘要

Giftlife® Single-Step Medium Plus 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 2024-11-22 under 510(k) number K242968. 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® Single-Step Medium Plus?

Giftlife® Single-Step Medium Plus is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K242968.

When did Giftlife® Single-Step Medium Plus receive FDA 510(k) clearance?

Giftlife® Single-Step Medium Plus received FDA 510(k) clearance on 2024-11-22, under 510(k) number K242968.

Who is the listed applicant for Giftlife® Single-Step Medium Plus?

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® Single-Step Medium Plus?

The FDA product code for Giftlife® Single-Step Medium Plus is MQL.

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 K240002G-Vitri™玻璃化吸管 K240149Giftlife™受精介质；Giftlife™分裂介质；Giftlife™囊胚介质；Giftlife™单步介质 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 Corporation K252672CaseBio® Culture w/HSA (CMH5)；CaseBio® Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin 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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