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510(k) Data Aggregation

    K Number
    K043132
    Device Name
    UNIVERSAL XACTTRACE
    Manufacturer
    MEDCARE FLAGA
    Date Cleared
    2004-12-21

    (39 days)

    Product Code
    MNR, BZQ, DEV
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE FLAGA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Universal XactTrace is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments. Universal XactTrace is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.
    Device Description
    The Universal XactTrace is a small battery powered reusable respiratory effort sensor. It incorporates electronics to measure and process a respiratory effort signal to provide an electrical signal suitable for connection to the inputs of a physiological recorder. The Universal XactTrace is composed of a sensor belt and a belt cable. The sensor belt has two types: abdomen belt that is applied around the patient's abdomen and thorax belt that is applied around the patient's thorax. The sensor belts are intended to be worn over clothing. The belt cable is used to connect the belt sensor to a physiological recorder. The Universal XactTrace is powered by a non replaceable battery that is built in the buckle of the sensor belt and switches on/off when the buckle is connected/unconnected. The Universal XactTrace is based on Respiratory Inductive Plethysmograph (RIP) technique.
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    K Number
    K041724
    Device Name
    COMPASS M10 SYSTEM
    Manufacturer
    MEDCARE FLAGA
    Date Cleared
    2004-09-28

    (96 days)

    Product Code
    MNR, DEV, FLS
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE FLAGA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Compass M10 system is to record physiological signals during sleep, scan the signals for abnormalities and represent the count of abnormal events in a form of a summary report. The results of the scan may be manually overwritten or corrected by the physician. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's count of abnormal events. It is not intended for any diagnosis. It is not intended to be a monitor. The Compass M10 system is intended to be used for adult and pediatric patients.
    Device Description
    The Compass M10 system is an ambulatory recording system. It includes a recording device, a signal adapter, respiratory effort sensors, strap system for attaching of recording device to a patient, an USB cable for data download and the Compass application. The Compass M10 device is a pocket size battery powered digital recorder that incorporates electronics to record and store one night of physiological parameters. It has two respiratory channels for measurement of thoracic and abdominal movements and a built-in body position and actigraph sensor for measurement of body position and movement. It also has an optional oximeter input to measure degree of oxygen saturation of the blood. The Compass application provides the means to prepare the device for recording, download the recorded data, viewing and analyzing the recorded data on a PC.
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    K Number
    K041904
    Device Name
    COMPASS F10 SYSTEM
    Manufacturer
    MEDCARE FLAGA
    Date Cleared
    2004-09-07

    (54 days)

    Product Code
    MNR, FLS
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE FLAGA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Compass F10 system is to record physiological signals during sleep, scan the signals for abnormalities and represent the count of abnormal events in a form of a summary report. The results of the scan may be manually overwritten or corrected by the physician. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's count of abnormal events. It is not intended for any diagnosis. It is not intended to be a monitor. The Compass F10 device is intended to be used for adult and pediatric patients.
    Device Description
    The Compass F10 system is an ambulatory recording system. It includes a recording device, a signal adapter, strap system for attaching of recording device to a patient, an USB cable for data download and the Compass application. The Compass F10 device is a pocket size battery powered digital recorder that incorporates electronics to record and store one night of physiological parameters. It has one respiratory channel for measurement of nasal pressure/airflow and a built-in body position and actigraph sensor for measurement of body position and movement. It also has an optional oximeter input to measure degree of oxygen saturation of the blood. The Compass application provides the means to prepare the device for recording, download the recorded data, viewing and analyzing the recorded data on a PC.
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    K Number
    K024322
    Device Name
    EMBLA N7000
    Manufacturer
    MEDCARE FLAGA
    Date Cleared
    2003-10-27

    (305 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE FLAGA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Embla N7000 is intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals and transmission of these signals to a PC during neurophysiologic or sleep examinations. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments. The use of the Embla N7000 system does not involve any patient monitoring or diagnosis.
    Device Description
    The Embla N7000 system is a full polysomnography system with expanded EEG capability. It is used to perform online sleep studies in the sleep lab, hospital or clinical environment under the supervision of a clinician or sleep technician. It does not do the recording, monitoring or analysis of this data. The Embla N7000 system integrates digital technology and precision engineering into a flexible, rugged, full polysomnography system. The system itself, featuring an Ethernet network connection, is simple to assemble and the cables have been streamlined to provide a comfortable and reliable system. Meeting the most demanding clinical and research needs by offering 32 referential EEG channels, 8 bipolar channels plus an extensive set of respiratory signals, the system also includes auxiliary inputs for additional devices such as CPAP and CO2 machines.
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