FDA 510(k)

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

Número K: K252160 · 2025-10-31

Data da decisão2025-10-31

Código do produtoOMB

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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