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

    MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)

    K Number: K250356 · Decision Jul 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    5
    Review Days
    172

    Basic Information

    Device Name
    MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
    K Number
    K250356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Infobionic, Inc.
    Date Received
    February 7, 2025
    Decision Date
    July 29, 2025
    Product Code
    DSI
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DSI Detector And Alarm, Arrhythmia

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    Other Clearances by Infobionic, Inc.

    K Number Device Name
    K230265 MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
    K160064 MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
    K152491 MoMe Software Platform
    K133753 MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR