FDA 510(k)

ActiGraph LEAP активный монитор (ActiGraph LEAP)

Номер K: K231532 · 2023-06-23

Дата решения2023-06-23

Код продуктаLEL

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: LEL)

K252981EmbraceMiniEmpatica S.r.l.K251574Sleep WatchAmbulatory Monitoring, Inc.K243513DCM (PW-DCM)Pneumowave, Ltd.K233987VERABAND™Arbor Medical Innovations, LLC K233618Oxevision Sleep DeviceOxehealth Limited K181077ActiGraph CentrePoint Insight WatchActigraph

Официальный источник

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