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FDA 510(k)

Persyst 15 EEG Review and Analysis Software

K-Number: K222002 · 2022-12-30

ApplicantPersyst Development Corporation
Decision Date2022-12-30
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Persyst 15 EEG Review and Analysis Software is a medical device manufactured by Persyst Development Corporation. It received FDA 510(k) clearance on 2022-12-30 under approval number K222002. 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 EEG Review and Analysis Software is a medical device that received FDA 510(k) clearance on 2022-12-30. It is manufactured by Persyst Development Corporation. The 510(k) number is K222002.

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

Persyst 15 EEG Review and Analysis Software received FDA 510(k) clearance on 2022-12-30, under approval number K222002.

What company makes Persyst 15 EEG Review and Analysis Software?

Persyst 15 EEG Review and Analysis Software is manufactured by Persyst Development Corporation.

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

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

Related Clinical Trials

NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07328555 Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING

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 K182181Persyst 14 EEG Review and Analysis Software K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

Related Devices (Code: OMB)

K171184Persyst Mobile AppPersyst Development Corporation K182181Persyst 14 EEG Review and Analysis SoftwarePersyst 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)

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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