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

    DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA

    K Number: K961150 · Decision Sep 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    15
    Review Days
    172

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    Basic Information

    Device Name
    DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA
    K Number
    K961150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hudson Respiratory Care, Inc.
    Date Received
    March 22, 1996
    Decision Date
    September 10, 1996
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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    K010402 SMOOTH-FLO CIRCUIT
    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
    K961914 BACTERIA/VIRAL FILTER
    K955645 CATH-GUIDE
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