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510(k) Data Aggregation

    K Number
    K103042
    Device Name
    ATMOS E 201 THORAX AND ATMOS S 201 THORAX
    Manufacturer
    ATMOS INC.
    Date Cleared
    2011-04-15

    (183 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATMOS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATMOS E 201 Thorax and the ATMOS S 201 Thorax are indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious material from a patient's respiratory support system after surgery. The general indication of the ATMOS S 201 Thorax and the ATMOS E 201 Thorax is thoracic drainage.
    Device Description
    The ATMOS S 201 Thorax and ATMOS E 201 Thorax drainage suction units are devices for mobile thoracic drainage. The devices are intended for short-time (<30 days) application on human beings. They are portable, mains independent and have an electronic monitoring system with optical and acoustic status display. The products are used in unsterile condition, except of the hose set and the collection container, which are sterile single-use products. Any trocars and catheters may be used which their manufacturers have intended for use in thoracic drainage. The ATMOS S 201 and the ATMOS E 201 Thorax are not intended for use in emergency medicine.
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    K Number
    K090130
    Device Name
    ATMOS S041 WOUND
    Manufacturer
    ATMOS INC.
    Date Cleared
    2009-04-02

    (71 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATMOS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATMOS S041 Wound™ is a suction device intended for aspiration and collection of secretions and body fluids from wounds and is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. ATMOS S041 is appropriate for use on the following wounds: - · Pressure ulcers - · Diabetic/neuropathic ulcers - · Venous insufficiency ulcers - Traumatic wounds - · Post-operative and dehisced surgical wounds - Explored fistulas - · Skin flaps and grafts
    Device Description
    The ATMOS S 041 Wound is a device to remove bodily fluids for wound drainage and can be used by patients over an extended period of time as recommended by a physician. The device has a rechargeable battery and therefore is portable. A microprocessor controlled electronic battery charging unit in the suction device guarantees the safe charging of the battery, and overcharging of the battery. The ATMOS S 041 Wound itself is not a sterile device but can use disposable (sterile) items from other manufacturers but these items are not a part of the S 041, (e.g. various hose sets, containers, trocars and catheters) which have been designed for the wound drainage.
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    K Number
    K090445
    Device Name
    ATMOS C361/C451 SUCTION PUMP
    Manufacturer
    ATMOS INC.
    Date Cleared
    2009-02-27

    (7 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATMOS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATMOS C361/C451 Suction Pump™ device is intended for aspiration and collection of secretions, body fluids and tissue from wounds during surgery or at the patient's bedside.
    Device Description
    The ATMOS C361/C451 device is an AC/DC-powered surgical suction unit. With a direct docking and direct docking disposable system, hose connection errors are not possible. There is only one connection for the hose to the patient. The connection from the jar to the pump is integrated in the container lid. The ATMOS C361/C451 is centered on a silent diaphragm-type pump which generates a vacuum inside the collection jar, allowing secretions to be withdrawn and collected. Using a vacuum regulator and the vacuum-gauge, the target vacuum and airflow rate can be adjusted.
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