FDA 510(k)

LOGIQ E10s, LOGIQ Fortis

K号: K211524 · 2021-08-27

决定日期2021-08-27

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

LOGIQ E10s, LOGIQ Fortis is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K211524. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LOGIQ E10s, LOGIQ Fortis?

LOGIQ E10s, LOGIQ Fortis is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is GE Healthcare. The 510(k) number is K211524.

When did LOGIQ E10s, LOGIQ Fortis receive FDA 510(k) clearance?

LOGIQ E10s, LOGIQ Fortis received FDA 510(k) clearance on 2021-08-27, under 510(k) number K211524.

Who is the listed applicant for LOGIQ E10s, LOGIQ Fortis?

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

What is the FDA product code for LOGIQ E10s, LOGIQ Fortis?

The FDA product code for LOGIQ E10s, LOGIQ Fortis is IYN.

列明GE Healthcare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。

K253639查看此医疗设备监管文本： View the medical-device regulatory text for this device_name.K242925MR Contour DL K232346数字专家访问与远程扫描 K223212Precision DL K221680Xeleris V 处理与审查系统 K221932Omni 传奇

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相关器械（代码：IYN）

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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