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510(k) Data Aggregation

    K Number
    K032736
    Device Name
    HEART 2006
    Manufacturer
    AEROTEL MEDICAL SYSTEMS (1998) LTD.
    Date Cleared
    2003-10-03

    (29 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEROTEL MEDICAL SYSTEMS (1998) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heart 2006 is a long-term portable electrocardiogram monitor intended to be used for long-term cardiac out-patient management. The unit records a period of electrocardiogram whenever the patient feels symptoms, as indicated to him by a physician, and presses a button on the unit. The electrocardiograms are then sent to the physician by telephone. The unit is indicated whenever it is desired to have electrocardiograms of a symptomatic patient at the time of the symptoms. There are no known contraindications.
    Device Description
    The Heart 2006 is a battery-powered ECG event recorder and transmitter that is capable of storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station. It records a portion of the ECG both before and after a "Record" button is depressed. The H2006 is a battery powered ECG Event Recorder and Transmitter which is intended to be used by the patient to record portions of a patient's electrocardiogram (ECG) and to send it to a receiving center such as Aerotel's Heartline Receiving Station (FDA # K022073) or equivalent. It records portions of the ECG both before and after the Record button is depressed.
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    K Number
    K030825
    Device Name
    MPM-NET
    Manufacturer
    AEROTEL MEDICAL SYSTEMS (1998) LTD.
    Date Cleared
    2003-03-28

    (14 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEROTEL MEDICAL SYSTEMS (1998) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aerotel Medical Systems (1998) Ltd. MPM-Net system is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports and charts showing the history of the systolic, diastolic pressures and the heart rate. The system is not intended for patients with defibrillators.
    Device Description
    The MPM-Net is an option for a modem/dialer system adapted for the purpose of following patients' blood pressures. It operates in conjunction with a cleared home-use blood pressure device. The system includes the computer program at a central station used for receiving data and preparing reports. The option allows reports to be retrieved over the internet.
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    K Number
    K023418
    Device Name
    HEARTONE EVENT RECORDER AND TRANSMITTER
    Manufacturer
    AEROTEL MEDICAL SYSTEMS (1998) LTD.
    Date Cleared
    2002-11-06

    (26 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEROTEL MEDICAL SYSTEMS (1998) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HeartOne is intended to be used as a Patient/physician activated single lead ECG data recorder/transmitter, for recording ECGs and transmitting them over telephone lines to Aerotel's Heartline Receiving Station The unit is indicated whenever it is desired to have single-lead electrocardiograms of a patient. There are no known contraindications.
    Device Description
    The HeartOne is a battery-powered ECG event recorder and transmitter that is capable of recording and storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station. The HeartOne is a battery powered post-event ECG Event Recorder and Transmitter which is intended to be used by the patient to record portions of a patient's electrocardiogram (ECG) and to send it to a receiving center such as the Aerotel Heartline Receiving Station K022073 or equivalent.
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    K Number
    K022073
    Device Name
    HEARTLINE RECEIVING STATION
    Manufacturer
    AEROTEL MEDICAL SYSTEMS (1998) LTD.
    Date Cleared
    2002-07-24

    (28 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEROTEL MEDICAL SYSTEMS (1998) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heartline is an ECG monitoring device intended to receive ECG signals over standard telephone lines from patient operated transmitters when decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment.
    Device Description
    The Heartline is an ECG monitoring device intended to receive ECG signals over standard telephone lines from patient operated transmitters. When decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment. The HRS is basically a software system, and operates on commercial personal computers. The device is compatible with all Aerotel monitors, all of which have been cleared by the FDA.
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    K Number
    K021447
    Device Name
    TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM
    Manufacturer
    AEROTEL MEDICAL SYSTEMS (1998) LTD.
    Date Cleared
    2002-05-22

    (16 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEROTEL MEDICAL SYSTEMS (1998) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aerotel Medical Systems (1998) Ltd Tele-CliniQ Data Transmission System is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit (purchased separaetly) and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports. The Tele-CliniQ is not intended for patients with defibrillators.
    Device Description
    The system includes a home blood-pressure measuring device that makes use of the oscillometric system (purchased separately), a means for sending the measurements over the telephone lines to a central station, and a computer program at the central station for receiving the measurements, storing them in a data base, and preparing reports.
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    K Number
    K000775
    Device Name
    HEART 2005
    Manufacturer
    AEROTEL MEDICAL SYSTEMS (1998) LTD.
    Date Cleared
    2000-05-17

    (69 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEROTEL MEDICAL SYSTEMS (1998) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983717
    Device Name
    BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM
    Manufacturer
    AEROTEL MEDICAL SYSTEMS (1998) LTD.
    Date Cleared
    1999-09-16

    (330 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEROTEL MEDICAL SYSTEMS (1998) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aerotel Medical Systems (1998) Ltd BP-Tel Trans-Telephonic Monitoring system is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports and charts showing the history of the systolic, diastolic pressures and the heart rate. The BP-Tel is not intended for patients with defibrillators.
    Device Description
    The system includes a home blood-pressure measuring device that makes use of the oscillometric system, a means for sending the measurements over the telephone lines to a central station, and a computer program at the central station for receiving the measurements, storing them in a data base, and preparing reports.
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