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

    TOTAL O2

    K Number: K013472 · Decision Nov 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    17
    Review Days
    41

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    Basic Information

    Device Name
    TOTAL O2
    K Number
    K013472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chad Therapeutics, Inc.
    Date Received
    October 18, 2001
    Decision Date
    November 28, 2001
    Product Code
    CAW
    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
    CAW Generator, Oxygen, Portable

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    K033364 CHAD THERAPEUTICS SAGE
    K020475 CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
    K010389 CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
    K003455 MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
    K000890 CHAD THERAPEUTICS OXYMATIC MODEL 401
    K971889 CHAD TOTAL O2 DELIVERY SYSTEM
    K884562 OXYMATIC-24
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