FDA 510(k)

Kitazato OPU 针

K号: K162881 · 2017-07-11

决定日期2017-07-11

产品代码MQE

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决定实质等同

器械摘要

Kitazato OPU Needles is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K162881. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Kitazato OPU Needles?

Kitazato OPU Needles is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Kitazato Corporation. The 510(k) number is K162881.

When did Kitazato OPU Needles receive FDA 510(k) clearance?

Kitazato OPU Needles received FDA 510(k) clearance on 2017-07-11, under 510(k) number K162881.

Who is the listed applicant for Kitazato OPU Needles?

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 Kitazato OPU Needles?

The FDA product code for Kitazato OPU Needles is MQE.

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：MQE）

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。

官方来源

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