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510(k) Data Aggregation

    K Number
    K080243
    Device Name
    PORTABLE OXYGEN UNIT SCA900
    Manufacturer
    SAN CHEONG CO. LTD.
    Date Cleared
    2009-04-07

    (432 days)

    Product Code
    CAN, ECX, KGA
    Regulation Number
    868.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAN CHEONG CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable Oxygen Unit SCA900 is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and oxygen cylinder fully integrated into single unit. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
    Device Description
    The Portable Oxygen Unit SCA900 is a portable oxygen delivery system, consisting of a fully integrated cylinder, valve, regulator, nasal cannula and mask. The oxygen is delivered through the mask or nasal cannula with a range of user-selectable flow settings. This unit is suitable for use in all healthcare settings. including hospital and home healthcare.
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