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

    AIRMED SMOKE EVACUATION & FILTER

    K Number: K820091 · Decision Feb 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    42

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    Basic Information

    Device Name
    AIRMED SMOKE EVACUATION & FILTER
    K Number
    K820091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    James L. Geraci & Associates, Inc.
    Date Received
    January 13, 1982
    Decision Date
    February 24, 1982
    Product Code
    CIE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CIE Volumetric/Manometric, Carbon-Dioxide

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    Other Clearances by James L. Geraci & Associates, Inc.

    K Number Device Name
    K853927 LASE SYSTEM II
    K820079 AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL
    K820078 DRAPE, SURGICAL
    K811698 CARL ZEISS INN MYRINGOTOMY TUBE LINE