ActiGraph CentrePoint Insight 手表
K号: K181077 · 2018-05-24
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申请人Actigraph
决定日期2018-05-24
产品代码LEL
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
ActiGraph CentrePoint Insight Watch is the device name listed in this FDA 510(k) record. The listed applicant is Actigraph. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K181077. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ActiGraph CentrePoint Insight Watch?
ActiGraph CentrePoint Insight Watch is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Actigraph. The 510(k) number is K181077.
When did ActiGraph CentrePoint Insight Watch receive FDA 510(k) clearance?
ActiGraph CentrePoint Insight Watch received FDA 510(k) clearance on 2018-05-24, under 510(k) number K181077.
Who is the listed applicant for ActiGraph CentrePoint Insight Watch?
The FDA 510(k) record lists Actigraph as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ActiGraph CentrePoint Insight Watch?
The FDA product code for ActiGraph CentrePoint Insight Watch is LEL.
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相关器械（代码：LEL）
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
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