BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    EchoS Family

    K Number: K202514 · Decision Feb 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    8
    Applicant Total
    3
    Review Days
    178

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    Basic Information

    Device Name
    EchoS Family
    K Number
    K202514
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1180
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Echolight S.P.A
    Date Received
    August 31, 2020
    Decision Date
    February 25, 2021
    Product Code
    MUA
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MUA Bone Sonometer

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    ACHILLES

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    Other Clearances by Echolight S.P.A

    K Number Device Name
    K212851 EchoSK and EchoSGyn modules for EchoS Family devices
    K180516 EchoS