FDA 510(k)

Voluson S6，Voluson S8，Voluson S8t，Voluson S10，Voluson S10 Expert

K号: K213642 · 2022-01-13

决定日期2022-01-13

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2022-01-13 under 510(k) number K213642. 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 Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is a medical device that received FDA 510(k) clearance on 2022-01-13. The listed applicant is GE Healthcare. The 510(k) number is K213642.

When did Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert receive FDA 510(k) clearance?

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert received FDA 510(k) clearance on 2022-01-13, under 510(k) number K213642.

Who is the listed applicant for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

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 Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

The FDA product code for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert 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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