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

    EMBRACE GEL

    K Number: K072515 · Decision Sep 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    33
    Applicant Total
    2
    Review Days
    13

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    Basic Information

    Device Name
    EMBRACE GEL
    K Number
    K072515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orison Corporation
    Date Received
    September 7, 2007
    Decision Date
    September 20, 2007
    Product Code
    MUI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    MUI Media, Coupling, Ultrasound

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    Other Clearances by Orison Corporation

    K Number Device Name
    K070477 ORISON EMBRACE SYSTEM