FDA 510(k)

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

Номер K: K252160 · 2025-10-31

Дата решения2025-10-31

Код продуктаOMB

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) is the device name listed in this FDA 510(k) record. The listed applicant is Persyst Development, LLC. It received FDA 510(k) clearance on 2025-10-31 under 510(k) number K252160. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))?

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) is a medical device that received FDA 510(k) clearance on 2025-10-31. The listed applicant is Persyst Development, LLC. The 510(k) number is K252160.

When did Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) receive FDA 510(k) clearance?

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) received FDA 510(k) clearance on 2025-10-31, under 510(k) number K252160.

Who is the listed applicant for Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))?

The FDA 510(k) record lists Persyst Development, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))?

The FDA product code for Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) is OMB.

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: OMB)

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K243743autoSCORE (V 2.0.0)Holberg Eeg AS K241589Ceribell Seizure Detection SoftwareCeribell, Inc.K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation K241390NeuroMatchLVIS Corporation

Официальный источник

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