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

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

    K Number: K242446 · Decision Jan 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    40
    Applicant Total
    6
    Review Days
    159

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    Basic Information

    Device Name
    Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
    K Number
    K242446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Persyst Development Corporation
    Date Received
    August 16, 2024
    Decision Date
    January 22, 2025
    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

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    Other Clearances by Persyst Development Corporation

    K Number Device Name
    K222002 Persyst 15 EEG Review and Analysis Software
    K182181 Persyst 14 EEG Review and Analysis Software
    K171184 Persyst Mobile App
    K151929 PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE
    K133793 PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE