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FDA 510(k)

GR40CW

K号: K181631 · 2018-07-20

决定日期2018-07-20
产品代码MQB
咨询委员会RA
决定实质等同

器械摘要

GR40CW is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K181631. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GR40CW?

GR40CW is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K181631.

When did GR40CW receive FDA 510(k) clearance?

GR40CW received FDA 510(k) clearance on 2018-07-20, under 510(k) number K181631.

Who is the listed applicant for GR40CW?

FDA 510(k)记录将三星电子株式会社列为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for GR40CW?

The FDA product code for GR40CW is MQB.

列明Samsung Electronics 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。

查看所有 26 个设备 →

相关器械(代码:MQB)

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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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。

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