泰斯OTCEMS系统，型号EM35
K号: K172241 · 2017-11-20
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申请人Tyece , Ltd.
决定日期2017-11-20
产品代码NGX
咨询委员会PM
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决定实质等同
器械摘要
Tyece OTC EMS System, Model EM35 is the device name listed in this FDA 510(k) record. The listed applicant is Tyece , Ltd.. It received FDA 510(k) clearance on 2017-11-20 under 510(k) number K172241. 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 Tyece OTC EMS System, Model EM35?
Tyece OTC EMS System, Model EM35 is a medical device that received FDA 510(k) clearance on 2017-11-20. The listed applicant is Tyece , Ltd.. The 510(k) number is K172241.
When did Tyece OTC EMS System, Model EM35 receive FDA 510(k) clearance?
Tyece OTC EMS System, Model EM35 received FDA 510(k) clearance on 2017-11-20, under 510(k) number K172241.
Who is the listed applicant for Tyece OTC EMS System, Model EM35?
The FDA 510(k) record lists Tyece , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tyece OTC EMS System, Model EM35?
The FDA product code for Tyece OTC EMS System, Model EM35 is NGX.
相关临床试验
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列明Tyece , 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。
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
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