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

    BEAMER ONE

    K Number: K894663 · Decision Sep 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    30
    Applicant Total
    18
    Review Days
    53

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    Basic Information

    Device Name
    BEAMER ONE
    K Number
    K894663
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Beacon Laboratories, Inc.
    Date Received
    July 24, 1989
    Decision Date
    September 15, 1989
    Product Code
    HAM
    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
    HAM Apparatus, Electrosurgical

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