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

    HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER

    K Number: K962220 · Decision Jan 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    32
    Review Days
    218

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    Basic Information

    Device Name
    HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
    K Number
    K962220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marquest Medical Products, Inc.
    Date Received
    June 10, 1996
    Decision Date
    January 14, 1997
    Product Code
    BZE
    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
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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    Other Clearances by Marquest Medical Products, Inc.

    K Number Device Name
    K050066 C-CO2 COLORIMETRIC CO2 INDICATOR
    K970478 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. →