FDA 510(k)

Cumulus 移除器

K号: K182002 · 2018-10-23

决定日期2018-10-23

产品代码MQL

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决定实质等同

器械摘要

Cumulus Remover is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2018-10-23 under 510(k) number K182002. 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 Cumulus Remover?

Cumulus Remover is a medical device that received FDA 510(k) clearance on 2018-10-23. The listed applicant is Kitazato Corporation. The 510(k) number is K182002.

When did Cumulus Remover receive FDA 510(k) clearance?

Cumulus Remover received FDA 510(k) clearance on 2018-10-23, under 510(k) number K182002.

Who is the listed applicant for Cumulus Remover?

The FDA 510(k) record lists Kitazato Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cumulus Remover?

The FDA product code for Cumulus Remover is MQL.

列明Kitazato Corporation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。

K260248超快速升温 K251305超快速玻璃化；超快速温控 K200249顺序培养基（受精培养基[无HSA/rHA，含HSA，含rHA]，分裂培养基[无HSA/rHA，含HSA，含rHA]，囊胚培养基[无HSA/rHA，含HSA，含rHA]）K193522iMedium 单步；iMedium 单步带HSA；iMedium 单步带rHA K192845精子冷冻，精子冰箱 K192540Kitazato ET 管套

查看所有 13 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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