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

    OXYGEN SUPPLY TUBING, MODEL 1115

    K Number: K011134 · Decision Jun 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    61
    Applicant Total
    15
    Review Days
    61

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    Basic Information

    Device Name
    OXYGEN SUPPLY TUBING, MODEL 1115
    K Number
    K011134
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5860
    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
    BYX
    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
    BYX Tubing, Pressure And Accessories

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