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

    PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400

    K Number: K073242 · Decision Jan 3, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    2
    Review Days
    45

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    Basic Information

    Device Name
    PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400
    K Number
    K073242
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Delphi Medical Systems
    Date Received
    November 19, 2007
    Decision Date
    January 3, 2008
    Product Code
    CAW
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    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 Delphi Medical Systems

    K Number Device Name
    K093332 DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)