FDA 510(k)

波电极（AE02-60）；波电极（AE02-50）

K号: K242326 · 2025-01-02

决定日期2025-01-02

产品代码GXY

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决定实质等同

器械摘要

Wave Electrode (AE02-60); Wave Electrode (AE02-50) is the device name listed in this FDA 510(k) record. The listed applicant is Bionit Labs Srl. It received FDA 510(k) clearance on 2025-01-02 under 510(k) number K242326. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wave Electrode (AE02-60); Wave Electrode (AE02-50)?

Wave Electrode (AE02-60); Wave Electrode (AE02-50) is a medical device that received FDA 510(k) clearance on 2025-01-02. The listed applicant is Bionit Labs Srl. The 510(k) number is K242326.

When did Wave Electrode (AE02-60); Wave Electrode (AE02-50) receive FDA 510(k) clearance?

Wave Electrode (AE02-60); Wave Electrode (AE02-50) received FDA 510(k) clearance on 2025-01-02, under 510(k) number K242326.

Who is the listed applicant for Wave Electrode (AE02-60); Wave Electrode (AE02-50)?

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

What is the FDA product code for Wave Electrode (AE02-60); Wave Electrode (AE02-50)?

The FDA product code for Wave Electrode (AE02-60); Wave Electrode (AE02-50) is GXY.

列明Bionit Labs Srl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。

K260453远程波电极（AE03-50）；远程波电极（AE03-60）

相关器械（代码：GXY）

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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官方来源

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