cryo-GO 冷冻玻璃化设备
K号: K241341 · 2024-09-26
广告
决定日期2024-09-26
产品代码MQK
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
cryo-GO Vitrification Device is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Irvine Scientific. It received FDA 510(k) clearance on 2024-09-26 under 510(k) number K241341. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the cryo-GO Vitrification Device?
cryo-GO Vitrification Device is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Fujifilm Irvine Scientific. The 510(k) number is K241341.
When did cryo-GO Vitrification Device receive FDA 510(k) clearance?
cryo-GO Vitrification Device received FDA 510(k) clearance on 2024-09-26, under 510(k) number K241341.
Who is the listed applicant for cryo-GO Vitrification Device?
The FDA 510(k) record lists Fujifilm Irvine Scientific as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for cryo-GO Vitrification Device?
The FDA product code for cryo-GO Vitrification Device is MQK.
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。
列明Fujifilm Irvine Scientific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。
相关器械（代码：MQK）
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。
K241626SperSort™ 精子分离芯片（IPG02）Ipreg IncorporationK241454Minvitro® 玻璃化吸管 (MVT-VSN 系列，包括 MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® 收割器（1 mL）；SwimCount® 收割器（3 mL）Motilitycount ApsK240002G-Vitri™玻璃化吸管Gimbo Medical Technology Shenzhen Co., Ltd.K232980SpermAlign 精子分离装置Cytoswim, Ltd.K233177Nest VT 液化设备Cook Incorporated
官方来源
在 FDA 数据库中查看 →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。
广告