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

    EpiWatch Monitoring System

    K Number: K243515 · Decision Mar 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    114

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    Basic Information

    Device Name
    EpiWatch Monitoring System
    K Number
    K243515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1580
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epiwatch, Inc.
    Date Received
    November 13, 2024
    Decision Date
    March 7, 2025
    Product Code
    POS
    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
    POS Physiological Signal Based Seizure Monitoring System

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