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

    ULTRASOUND TRANSMISSION GEL

    K Number: K905545 · Decision Mar 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    8
    Applicant Total
    15
    Review Days
    108

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    Basic Information

    Device Name
    ULTRASOUND TRANSMISSION GEL
    K Number
    K905545
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Arbo Medical, Inc.
    Date Received
    December 11, 1990
    Decision Date
    March 29, 1991
    Product Code
    JOT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOT Electrode, Gel, Electrosurgical

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