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

    SCT 3000 HEATED HUMIDIFIER

    K Number: K970478 · Decision Jul 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    32
    Review Days
    159

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    Basic Information

    Device Name
    SCT 3000 HEATED HUMIDIFIER
    K Number
    K970478
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marquest Medical Products, Inc.
    Date Received
    February 7, 1997
    Decision Date
    July 16, 1997
    Product Code
    BTT
    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Marquest Medical Products, Inc.

    K Number Device Name
    K050066 C-CO2 COLORIMETRIC CO2 INDICATOR
    K962220 HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
    K962223 WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
    K960972 DISPOSABLE GAS SAMPLING INTERFACE KITS
    K961838 RESPIRGARD II, SPIROGARD
    K904690 TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM
    K903138 MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM
    K902632 GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
    K903307 TEMP MARQ TEMPERATURE TREND INDICATOR
    K880979 MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM
    Search all 32 clearances from Marquest Medical Products, Inc. →