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FDA 510(k)

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

K-Number: K252160 · 2025-10-31

ApplicantPersyst Development, LLC
Decision Date2025-10-31
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Persyst Development, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))K222002Persyst 15 EEG Review and Analysis SoftwareK182181Persyst 14 EEG Review and Analysis SoftwareK171184Persyst Mobile App

Related Devices (Code: OMB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K243743autoSCORE (V 2.0.0)Holberg Eeg ASK241589Ceribell Seizure Detection SoftwareCeribell, Inc.K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development CorporationK241390NeuroMatchLVIS Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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