OGYILI TENS/NMES 刺激器
K号: K201431 · 2020-11-09
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决定日期2020-11-09
产品代码GZJ
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
OGYILI TENS/NMES Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Gongguan Tutamen Metalwork Co., Ltd.. It received FDA 510(k) clearance on 2020-11-09 under 510(k) number K201431. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OGYILI TENS/NMES Stimulator?
OGYILI TENS/NMES Stimulator is a medical device that received FDA 510(k) clearance on 2020-11-09. The listed applicant is Gongguan Tutamen Metalwork Co., Ltd.. The 510(k) number is K201431.
When did OGYILI TENS/NMES Stimulator receive FDA 510(k) clearance?
OGYILI TENS/NMES Stimulator received FDA 510(k) clearance on 2020-11-09, under 510(k) number K201431.
Who is the listed applicant for OGYILI TENS/NMES Stimulator?
The FDA 510(k) record lists Gongguan Tutamen Metalwork Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OGYILI TENS/NMES Stimulator?
The FDA product code for OGYILI TENS/NMES Stimulator is GZJ.
相关临床试验
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相关器械（代码：GZJ）
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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