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

    EMG MODEL SUA01 SUCTION UNIT

    K Number: K042349 · Decision Dec 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    76
    Applicant Total
    11
    Review Days
    108

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    Basic Information

    Device Name
    EMG MODEL SUA01 SUCTION UNIT
    K Number
    K042349
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Emg Technology Co., Ltd.
    Date Received
    August 30, 2004
    Decision Date
    December 16, 2004
    Product Code
    JCX
    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
    JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

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