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

    NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI

    K Number: K011125 · Decision Jun 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    41
    Applicant Total
    15
    Review Days
    61

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    Basic Information

    Device Name
    NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
    K Number
    K011125
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5340
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hudson Respiratory Care, Inc.
    Date Received
    April 13, 2001
    Decision Date
    June 13, 2001
    Product Code
    CAT
    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
    CAT Cannula, Nasal, Oxygen

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    Other Clearances by Hudson Respiratory Care, Inc.

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    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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