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

    CHAD TOTAL O2 DELIVERY SYSTEM

    K Number: K971889 · Decision Nov 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    17
    Review Days
    180

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    Basic Information

    Device Name
    CHAD TOTAL O2 DELIVERY SYSTEM
    K Number
    K971889
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chad Therapeutics, Inc.
    Date Received
    May 21, 1997
    Decision Date
    November 17, 1997
    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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    Other Clearances by Chad Therapeutics, Inc.

    K Number Device Name
    K081176 FLOCHANNEL
    K070740 CHAD THERAPEUTICS BONSAI MODEL 800
    K042142 CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
    K033364 CHAD THERAPEUTICS SAGE
    K020475 CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
    K013472 TOTAL O2
    K010389 CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
    K003455 MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
    K000890 CHAD THERAPEUTICS OXYMATIC MODEL 401
    K884562 OXYMATIC-24
    Search all 17 clearances from Chad Therapeutics, Inc. →