FDA 510(k)

SAGE 玻璃化试剂盒和SAGE 玻璃化加热试剂盒

K号: K170560 · 2017-04-04

决定日期2017-04-04

产品代码MQL

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决定实质等同

器械摘要

SAGE Vitrification Kit and SAGE Vitrification Warming Kit is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2017-04-04 under 510(k) number K170560. 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 SAGE Vitrification Kit and SAGE Vitrification Warming Kit?

SAGE Vitrification Kit and SAGE Vitrification Warming Kit is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K170560.

When did SAGE Vitrification Kit and SAGE Vitrification Warming Kit receive FDA 510(k) clearance?

SAGE Vitrification Kit and SAGE Vitrification Warming Kit received FDA 510(k) clearance on 2017-04-04, under 510(k) number K170560.

Who is the listed applicant for SAGE Vitrification Kit and SAGE Vitrification Warming Kit?

FDA 510(k)记录中列出CooperSurgical, Inc.为申请人。这本身并不足以确立设备制造商。

What is the FDA product code for SAGE Vitrification Kit and SAGE Vitrification Warming Kit?

The FDA product code for SAGE Vitrification Kit and SAGE Vitrification Warming Kit is MQL.

列明CooperSurgical, Inc.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。

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）K243799复杂腹裂胎儿修复：一项安全性和可行性试验 K250438CooperSurgical Milex® 子宫托 K223064ALLY II子宫定位系统™（UPS）K201086Advincula Delineator 宫腔操纵器 K200038Endosee System

查看所有 16 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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