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510(k) Data Aggregation

    K Number
    K091871
    Device Name
    DK50 DS
    Manufacturer
    EKOM S.R.O.
    Date Cleared
    2009-10-23

    (122 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    EKOM S.R.O.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for supplying compressed air for medical ventilators.
    Device Description
    The Ekom model DK50 DS is a portable air compressor designed to supply air to medical equipment, i.e., ventilators. The Model DK50 DS contain an oil-free piston compressor driven by a low maintenance single phase electric motor. Compressed air is cooled where condensed water is separated into a vessel. Incoming air passes through 2 filters and undergoes double filtration as it passes through the system. Constant output pressure is maintained by a pressure regulator. There is a built-in air tank which allows peak air consumption of 200 Lpm. The device may be used as a standby source of air. In this configuration, the respiratory equipment is supplied with compressed air from the facilities central air distribution. Air pressure in this central distribution is sensed by the Ekom pressure sensor. If the pressure is sufficient, the compressor stays in the STANDBY mode. If the pressure falls the compressor automatically starts and becomes the main air supply. When the compressor is used as the main source, the control unit determines its operation according to the current need for air. If air consumption is zero, the device switches to STANDBY. The compressor is equipped with indicators for output pressure, operation hours, power status, drying efficiency and battery condition as well as acoustic and optic alarms to warn of high operating temperature, low output pressure and loss power.
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    K Number
    K060781
    Device Name
    MEDICAL COMPRESSOR, MODELS DK50 D AND DM
    Manufacturer
    EKOM S.R.O.
    Date Cleared
    2006-10-03

    (195 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    EKOM S.R.O.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DK50 D and DK50 DM Medical Compressors are indicated for supplying compressed air for medical ventilators.
    Device Description
    The DK50 D and DK50 DM Medical Compressors are electric and produces air from the normal environment to supply compressed air for medical ventilators.
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