ActiGraph LEAP 活动监测器（ActiGraph LEAP）
K号: K231532 · 2023-06-23
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决定日期2023-06-23
产品代码LEL
咨询委员会NE
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器械摘要
ActiGraph LEAP activity monitor (ActiGraph LEAP) is the device name listed in this FDA 510(k) record. The listed applicant is Actigraph, LLC. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K231532. 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 LEAP activity monitor (ActiGraph LEAP)?
ActiGraph LEAP activity monitor (ActiGraph LEAP) is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Actigraph, LLC. The 510(k) number is K231532.
When did ActiGraph LEAP activity monitor (ActiGraph LEAP) receive FDA 510(k) clearance?
ActiGraph LEAP activity monitor (ActiGraph LEAP) received FDA 510(k) clearance on 2023-06-23, under 510(k) number K231532.
Who is the listed applicant for ActiGraph LEAP activity monitor (ActiGraph LEAP)?
The FDA 510(k) record lists Actigraph, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ActiGraph LEAP activity monitor (ActiGraph LEAP)?
The FDA product code for ActiGraph LEAP activity monitor (ActiGraph LEAP) is LEL.
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相关器械（代码：LEL）
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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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