BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    EchoGo Amyloidosis (1.0)

    K Number: K240860 · Decision Nov 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    232

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    Basic Information

    Device Name
    EchoGo Amyloidosis (1.0)
    K Number
    K240860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ultromics Limited
    Date Received
    March 28, 2024
    Decision Date
    November 15, 2024
    Product Code
    SDJ
    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
    SDJ Adjunctive Cardiac Amyloidosis Status Indicator

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