MyoCycle MC-2 (家用 / 家用+ / 专业 / 专业+)
K号: K213925 · 2022-04-25
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申请人Myolyn, LLC
决定日期2022-04-25
产品代码GZI
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
MyoCycle MC-2 (Home / Home + / Pro / Pro +) is the device name listed in this FDA 510(k) record. The listed applicant is Myolyn, LLC. It received FDA 510(k) clearance on 2022-04-25 under 510(k) number K213925. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MyoCycle MC-2 (Home / Home + / Pro / Pro +)?
MyoCycle MC-2 (Home / Home + / Pro / Pro +) is a medical device that received FDA 510(k) clearance on 2022-04-25. The listed applicant is Myolyn, LLC. The 510(k) number is K213925.
When did MyoCycle MC-2 (Home / Home + / Pro / Pro +) receive FDA 510(k) clearance?
MyoCycle MC-2 (Home / Home + / Pro / Pro +) received FDA 510(k) clearance on 2022-04-25, under 510(k) number K213925.
Who is the listed applicant for MyoCycle MC-2 (Home / Home + / Pro / Pro +)?
The FDA 510(k) record lists Myolyn, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MyoCycle MC-2 (Home / Home + / Pro / Pro +)?
The FDA product code for MyoCycle MC-2 (Home / Home + / Pro / Pro +) is GZI.
相关临床试验
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列明Myolyn, LLC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：GZI）
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
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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