XBody Go 美国，XBody Pro 美国
K号: K242926 · 2025-05-30
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决定日期2025-05-30
产品代码NGX
咨询委员会PM
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
XBody Go USA, XBody Pro USA is the device name listed in this FDA 510(k) record. The listed applicant is Xbody Hungary Kft.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K242926. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the XBody Go USA, XBody Pro USA?
XBody Go USA, XBody Pro USA is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Xbody Hungary Kft.. The 510(k) number is K242926.
When did XBody Go USA, XBody Pro USA receive FDA 510(k) clearance?
XBody Go USA, XBody Pro USA received FDA 510(k) clearance on 2025-05-30, under 510(k) number K242926.
Who is the listed applicant for XBody Go USA, XBody Pro USA?
The FDA 510(k) record lists Xbody Hungary Kft. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XBody Go USA, XBody Pro USA?
The FDA product code for XBody Go USA, XBody Pro USA is NGX.
相关临床试验
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。
列明Xbody Hungary Kft.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。
相关器械（代码：NGX）
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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