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

    SMOOTH-FLO CIRCUIT

    K Number: K010402 · Decision Mar 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    15
    Review Days
    30

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    Basic Information

    Device Name
    SMOOTH-FLO CIRCUIT
    K Number
    K010402
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hudson Respiratory Care, Inc.
    Date Received
    February 12, 2001
    Decision Date
    March 14, 2001
    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 Hudson Respiratory Care, Inc.

    K Number Device Name
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    K001213 CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60
    K993355 HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
    K994352 SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
    K964719 HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
    K961150 DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA
    K961914 BACTERIA/VIRAL FILTER
    K955645 CATH-GUIDE
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