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

    HeartBeam AIMIGo(TM) System

    K Number: K231424 · Decision Dec 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    2
    Review Days
    576

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    Basic Information

    Device Name
    HeartBeam AIMIGo(TM) System
    K Number
    K231424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heartbeam, Inc.
    Date Received
    May 17, 2023
    Decision Date
    December 13, 2024
    Product Code
    MWJ
    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
    MWJ Electrocardiograph, Ambulatory (Without Analysis)

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    Other Clearances by Heartbeam, Inc.

    K Number Device Name
    K250258 HeartBeam AIMIGo with 12-L ECG Synthesis Software System