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FDA 510(k)

Persyst 14 EEG Review and Analysis Software

K-Number: K182181 · 2018-11-29

ApplicantPersyst Development Corporation
Decision Date2018-11-29
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Persyst 14 EEG Review and Analysis Software is a medical device manufactured by Persyst Development Corporation. It received FDA 510(k) clearance on 2018-11-29 under approval number K182181. 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 14 EEG Review and Analysis Software?

Persyst 14 EEG Review and Analysis Software is a medical device that received FDA 510(k) clearance on 2018-11-29. It is manufactured by Persyst Development Corporation. The 510(k) number is K182181.

When was Persyst 14 EEG Review and Analysis Software approved by the FDA?

Persyst 14 EEG Review and Analysis Software received FDA 510(k) clearance on 2018-11-29, under approval number K182181.

What company makes Persyst 14 EEG Review and Analysis Software?

Persyst 14 EEG Review and Analysis Software is manufactured by Persyst Development Corporation.

What is the FDA product code for Persyst 14 EEG Review and Analysis Software?

The FDA product code for Persyst 14 EEG Review and Analysis Software 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)

Other Devices by Persyst Development Corporation

K171184Persyst Mobile App K222002Persyst 15 EEG Review and Analysis Software K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

Related Devices (Code: OMB)

K171184Persyst Mobile AppPersyst Development Corporation K171720encevisAit Austrian Institute of Technology GmbH K180421Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) K191301Ceribell Pocket EEG DeviceCeribell, Inc. K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) K211452EncevisAustrian Institute of Technology GmbH

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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