BEUDAMED
    Product Code: OMB FDA class 2 21 CFR 882.1400

    Automatic Event Detection Software For Full-Montage Electroencephalograph

    Neurology

    The Automatic Event Detection Software For Full-Montage Electroencephalograph (product code OMB) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It automatically marks or identifies EEG waveforms for spikes, electrographic seizures, and seizure-like events to aid in reviewing and annotating prolonged EEG traces, with all output subject to verification by a qualified user. The device is not eligible for third-party review and is not an implant or life-sustaining device.

    View on FDA
    510(k)s
    41
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    23
    Years Active
    39

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    Basic Information

    Product Code
    OMB
    Device Class
    FDA class 2
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 41 510(k) clearances via K numbers.

    K Number Device Name
    K252070 Ceribell Infant Seizure Detection Software
    K252160 Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
    K243743 autoSCORE (V 2.0.0)
    K241589 Ceribell Seizure Detection Software
    K242446 Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
    K241390 NeuroMatch
    K240408 REMI-AI Rapid Detection Module (REMI-AI RDM)
    K240993 encevis (2.1)
    K231068 autoSCORE
    K231779 REMI AI Discrete Detection Module
    K222450 LVIS NeuroMatch
    K223504 Ceribell Status Epilepticus Monitor
    K222002 Persyst 15 EEG Review and Analysis Software
    K211452 Encevis
    K200878 Natus NeuroWorks
    K191301 Ceribell Pocket EEG Device
    K182181 Persyst 14 EEG Review and Analysis Software
    K171720 encevis
    K180421 Natus NeuroWorks
    K171184 Persyst Mobile App
    K150688 IdentEvent
    K151929 PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE
    K141883 CLINISCANSM EEG
    K140552 CADWELL SPIKE AND SEIZURE DETECTOR
    K133793 PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE
    K132306 PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
    K120260 ICTA
    K090019 NATUS NEUROWORKS, MODEL 104196
    K092039 IDENTEVENT, VERSION 1.0G
    K042223 XLTEK CONNEX IP HEADBOX, MODEL 1054
    K011397 PERSYST REVEAL
    K010085 EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
    K002332 EEG SPIKE AND EVENT DETECTOR MODULE
    K960273 HARMONIE SENSA
    K955787 DIGITRACE HOME VIDEO SYSTEM
    K951594 BIO-LOGIC AUTOMATIC EVENT ANALYSIS
    K950270 NMI SOFTWARE
    K944833 DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM
    K950117 PERSYST SPIKE DETECTOR
    K910771 DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX
    K870450 SZAC-16 SEIZURE ANALYSIS COMPUTER

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.