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510(k) Data Aggregation

    K Number
    K023120
    Device Name
    OXYCON MOBILE
    Manufacturer
    ERICH JAEGER GMBH
    Date Cleared
    2003-11-12

    (419 days)

    Product Code
    BZC
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERICH JAEGER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jaeger OXYCON MOBILE pulmonary function mobile test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The OXYCON MOBILE system allows the use of telemetry for the monitoring of metabolic parameters. The OXYCON MOBILE system is intended to use with adults and children over the age of 14 years.
    Device Description
    Not Found
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    K Number
    K023796
    Device Name
    MS PAED-BABY BODY
    Manufacturer
    ERICH JAEGER GMBH
    Date Cleared
    2003-03-03

    (110 days)

    Product Code
    CCM
    Regulation Number
    868.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERICH JAEGER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MS PAED - BABY BODY is a neonatal lung function measurement system that utilizes a bodyplethysmograph. It is intended to be used under the direction of a physician. MS PAED - BABY BODY may be used in the clinic, doctors office, or hospital. Patient population that may benefit from the use of this device include only babies and premature infants. The MS PAED – BABY BODY, or any of the accessories supplied with it, is not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system.
    Device Description
    The MS PAED - BABY BODY is a local moveable device for the determination of airway resistance, absolute lung volume at FRC and tidal breathing patterns of babies and infants. Equipped with a computer and the Baby-Bodyplethysmography program the software is extremely easy to use, allows you to very quickly make several measurements and tolerates less experienced operators. The operator is to be guided through the program. The built in quality checks of the program prompt the user about a bad performed manoeuvre or an unacceptably low quality of the measurement. The body plethysmography measurement is provided with a reanalysis mode, which means that the physician can modify all data whenever required thereby eliminating the need for patients to return for additional measurements.
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    K Number
    K021138
    Device Name
    SLEEPSCREEN/APNOESCREEN CARDIO
    Manufacturer
    ERICH JAEGER GMBH
    Date Cleared
    2003-02-12

    (309 days)

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

    ERICH JAEGER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SleepScreen and ApnoeScreen Cardio are portable physiological signal recording devices intended to be used for testing patients suspected of having sleep-related breathing disorders. They are intended to be used under the direction of a physician. The devices may be used in the home, clinic, doctor's office or hospital. The SleepScreen and ApnoeScreen Cardio, or any of the accessories supplied with it, are not to be used, alone or in combination, as an apnea monitor or as a component in an apnea monitoring system. The SleepScreen and ApnoeScreen Cardio, or any of the accessories supplied with it, are not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system. The SleepScreen and ApnoeScreen Cardio are non-life-supporting portable physiological signal recording devices intended to be used for testing patients 7 years and older suspected of having sleep-related breathing disorders. The SleepScreen and ApnoeScreen Cardio are intended to measure and record oxygen saturation, pulse rate, body position, snoring, respiratory airflow, respiratory effort, PLM, EEG, EMG, EOG and ECG data. The devices may be used in the home, clinic, doctor's office or hospital. The SleepScreen and ApnoeScreen Cardio are not intended for use as an apnea monitor or as a component in an apnea monitoring system. Additionally, the SleepScreen and ApnoeScreen Cardio are not intended to be used alone or in combination with another product as a life support device, a life support system, or as a critical component to a life support device or system. There is no claim of compatibility with diagnostic imaging equipment.
    Device Description
    The ApnoeScreen Cardio is the ApnoeScreen Pro (K000396) with the addition of two AC channels. The additional AC channels may be used to record electro-oculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG). The SleepScreen is the ApnoeScreen Pro (K000396) with the addition of eight AC channels. The additional AC channels may be used to record electrooculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG).
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    K Number
    K001502
    Device Name
    AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO
    Manufacturer
    ERICH JAEGER GMBH
    Date Cleared
    2000-07-12

    (58 days)

    Product Code
    BZC
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERICH JAEGER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000648
    Device Name
    SPIRO PRO
    Manufacturer
    ERICH JAEGER GMBH
    Date Cleared
    2000-03-29

    (30 days)

    Product Code
    BTY
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERICH JAEGER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K980876
    Device Name
    ASTHMA MONITOR AM2
    Manufacturer
    ERICH JAEGER GMBH & CO. KG
    Date Cleared
    1998-08-14

    (161 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERICH JAEGER GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Asthma Monitor AM2 from JAEGER is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75. The AM2 is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management. The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEVI). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician. The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life' status. When enabled, the AM2 can be programmed with up to 12 questions, where the patient can select then from up to 7 different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS. The AM2 is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM2 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.
    Device Description
    The Asthma Monitor AM2 from JAEGER is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75. The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEVI). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician. The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life' status. When enabled, the AM2 can be programmed with up to 12 questions, where the patient can select then from up to 7 different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS. The AM2 is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM2 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.
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