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

    SMARTVAC SMOKE EVACUATION SYSTEM

    K Number: K970352 · Decision Nov 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    278

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    Basic Information

    Device Name
    SMARTVAC SMOKE EVACUATION SYSTEM
    K Number
    K970352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Isomedix Operations, Inc.
    Date Received
    January 30, 1997
    Decision Date
    November 4, 1997
    Product Code
    FYD
    Advisory Committee
    General, Plastic Surgery
    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
    FYD Apparatus, Exhaust, Surgical

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    Other Clearances by Isomedix Operations, Inc.

    K Number Device Name
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