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

    Ultrast Gel

    K Number: K211691 · Decision Dec 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    Ultrast Gel
    K Number
    K211691
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ultrast, Inc.
    Date Received
    June 2, 2021
    Decision Date
    December 22, 2021
    Product Code
    MUI
    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
    MUI Media, Coupling, Ultrasound

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