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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 a medical device manufactured by Persyst Development, LLC. It received FDA 510(k) clearance on 2025-10-31 under approval 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. It is manufactured by Persyst Development, LLC. The 510(k) number is K252160.

When was Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) approved by the FDA?

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

What company makes Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))?

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) is manufactured by Persyst Development, LLC.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 42180407 Global pharmacovigilance reporting: comparative analysis of adverse event obligations across five major regulatory authorities. Frontiers in drug safety and regulation (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42107714 Global approval and certification of ophthalmic AI devices: A comparative regulatory perspective. Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) (2026)

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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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