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FDA 510(k)

Elvie Stride 2

K号: K242125 · 2024-09-27

决定日期2024-09-27
产品代码HGX
咨询委员会OB 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Elvie Stride 2 is the device name listed in this FDA 510(k) record. The listed applicant is Chiaro Technology, Ltd.. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K242125. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elvie Stride 2?

Elvie Stride 2 is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Chiaro Technology, Ltd.. The 510(k) number is K242125.

When did Elvie Stride 2 receive FDA 510(k) clearance?

Elvie Stride 2 received FDA 510(k) clearance on 2024-09-27, under 510(k) number K242125.

Who is the listed applicant for Elvie Stride 2?

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

What is the FDA product code for Elvie Stride 2?

The FDA product code for Elvie Stride 2 is HGX.

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相关器械(代码:HGX)

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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