FDA 510(k)

SENSOSEEG 深部电极

K号: K213170 · 2023-04-18

决定日期2023-04-18

产品代码GZL

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决定实质等同

器械摘要

SENSOSEEG Depth Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Sensomedical Labs, Ltd.. It received FDA 510(k) clearance on 2023-04-18 under 510(k) number K213170. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SENSOSEEG Depth Electrodes?

SENSOSEEG Depth Electrodes is a medical device that received FDA 510(k) clearance on 2023-04-18. The listed applicant is Sensomedical Labs, Ltd.. The 510(k) number is K213170.

When did SENSOSEEG Depth Electrodes receive FDA 510(k) clearance?

SENSOSEEG Depth Electrodes received FDA 510(k) clearance on 2023-04-18, under 510(k) number K213170.

Who is the listed applicant for SENSOSEEG Depth Electrodes?

The FDA 510(k) record lists Sensomedical Labs, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSOSEEG Depth Electrodes?

The FDA product code for SENSOSEEG Depth Electrodes is GZL.

列明Sensomedical Labs, 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。

K253970沃温深度电极

相关器械（代码：GZL）

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。

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