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

    EchoGo Heart Failure (2.0)

    K Number: K240013 · Decision Sep 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    4
    Review Days
    265

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    Basic Information

    Device Name
    EchoGo Heart Failure (2.0)
    K Number
    K240013
    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
    January 2, 2024
    Decision Date
    September 23, 2024
    Product Code
    QUO
    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
    QUO Adjunctive Heart Failure Status Indicator

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    Other Clearances by Ultromics Limited

    K Number Device Name
    K240860 EchoGo Amyloidosis (1.0)
    K222463 EchoGo Heart Failure
    K213275 EchoGo Core (2.0)