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

    MEDI-VAC FLEXI-CLEAR SUCTION HANDLE

    K Number: K964127 · Decision Dec 31, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    193
    Registration Numbers
    193
    Same Product Code
    86
    Applicant Total
    63
    Review Days
    77

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    Basic Information

    Device Name
    MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
    K Number
    K964127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Allegiance Healthcare Corp.
    Date Received
    October 15, 1996
    Decision Date
    December 31, 1996
    Product Code
    GCX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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