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

    ULTRASOUND TRANSDUCER GEL, STERILE

    K Number: K871565 · Decision Jul 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    8
    Applicant Total
    10
    Review Days
    84

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    Basic Information

    Device Name
    ULTRASOUND TRANSDUCER GEL, STERILE
    K Number
    K871565
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Amedic USA
    Date Received
    April 22, 1987
    Decision Date
    July 15, 1987
    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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