BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    IdentEvent

    K Number: K150688 · Decision Nov 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    233

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    IdentEvent
    K Number
    K150688
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Optima Neuroscience, Inc.
    Date Received
    March 17, 2015
    Decision Date
    November 5, 2015
    Product Code
    OMB
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OMB Automatic Event Detection Software For Full-Montage Electroencephalograph

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OMB), ordered by most recent decision date.

    Ceribell Infant Seizure Detection Software

    FDA 510(k)
    FDA Class 2 ·Neurology

    Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ceribell Seizure Detection Software

    FDA 510(k)
    FDA Class 2 ·Neurology

    autoSCORE (V 2.0.0)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

    FDA 510(k)
    FDA Class 2 ·Neurology

    NeuroMatch

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Optima Neuroscience, Inc.

    K Number Device Name
    K092039 IDENTEVENT, VERSION 1.0G