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510(k) K242446

Device
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
Applicant
Persyst Development Corporation
510(k) number
K242446
Product code
OMB
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-22
Date received
2024-08-16
Regulation
882.1400
Classification name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Dari Darabbeigi
Address
420 Stevens Ave., Suite 210 Solana Beach CA US 92075 92075

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OMB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLC2025-10-31
K243743autoSCORE (V 2.0.0)Holberg Eeg AS2025-04-09
K241589Ceribell Seizure Detection SoftwareCeribell, Inc.2025-04-09
K241390NeuroMatchLVIS Corporation2024-11-26
K240408REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc.2024-10-17
K240993encevis (2.1)Ait Austrian Institute of Technology GmbH2024-09-27
K231068autoSCOREHolberg Eeg AS2024-01-07
K231779REMI AI Discrete Detection ModuleEpitel, Inc.2024-01-03
K222450LVIS NeuroMatchLVIS Corporation2023-06-09
K223504Ceribell Status Epilepticus MonitorCeribell, Inc.2023-05-23
K222002Persyst 15 EEG Review and Analysis SoftwarePersyst Development Corporation2022-12-30
K211452EncevisAustrian Institute of Technology GmbH2021-12-02
K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2020-05-18
K191301Ceribell Pocket EEG DeviceCeribell, Inc.2019-09-11
K182181Persyst 14 EEG Review and Analysis SoftwarePersyst Development Corporation2018-11-29