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

    HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER

    K Number: K862020 · Decision Jun 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    72
    Applicant Total
    10
    Review Days
    33

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    Basic Information

    Device Name
    HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER
    K Number
    K862020
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Intertech/Ohio
    Date Received
    May 28, 1986
    Decision Date
    June 30, 1986
    Product Code
    BYD
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BYD Condenser, Heat And Moisture (Artificial Nose)

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