BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DRAGER GEMINA WALL-MOUNTED WORKPLACE

    K Number: K961886 · Decision Jul 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    34
    Applicant Total
    10
    Review Days
    76

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    Basic Information

    Device Name
    DRAGER GEMINA WALL-MOUNTED WORKPLACE
    K Number
    K961886
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4960
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alm Surgical Equipment, Inc.
    Date Received
    May 15, 1996
    Decision Date
    July 30, 1996
    Product Code
    FQO
    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
    FQO Table, Operating-Room, Ac-Powered

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