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Found 7 results
510(k) Data Aggregation
K Number
K032736Device Name
HEART 2006
Manufacturer
AEROTEL MEDICAL SYSTEMS (1998) LTD.
Date Cleared
2003-10-03
(29 days)
Product Code
DXH
Regulation Number
870.2920Why 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
K030825Device Name
MPM-NET
Manufacturer
AEROTEL MEDICAL SYSTEMS (1998) LTD.
Date Cleared
2003-03-28
(14 days)
Product Code
DXN
Regulation Number
870.1130Why 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
K023418Device Name
HEARTONE EVENT RECORDER AND TRANSMITTER
Manufacturer
AEROTEL MEDICAL SYSTEMS (1998) LTD.
Date Cleared
2002-11-06
(26 days)
Product Code
DXH
Regulation Number
870.2920Why 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
K022073Device Name
HEARTLINE RECEIVING STATION
Manufacturer
AEROTEL MEDICAL SYSTEMS (1998) LTD.
Date Cleared
2002-07-24
(28 days)
Product Code
DXH
Regulation Number
870.2920Why 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
K021447Device 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
870.1130Why 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
K000775Device Name
HEART 2005
Manufacturer
AEROTEL MEDICAL SYSTEMS (1998) LTD.
Date Cleared
2000-05-17
(69 days)
Product Code
DXH
Regulation Number
870.2920Why 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
K983717Device 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
870.1130Why 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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