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510(k) Data Aggregation
K Number
K113514Device Name
SMARTHEART
Manufacturer
SHL TELEMEDICINE INTERNATIONAL LTD.
Date Cleared
2012-02-22
(86 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
SHL TELEMEDICINE INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Smartheart device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Smartheart device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to enable review at a physician's office, hospital or other medical receiving center.
Device Description
The Smartheart is a personal, hand-held battery powered. 12 lead ECG and rhythm strip device with Bluetooth connection. The Smartheart acquires ECG data via attached electrodes. The Smartheart transmits the data in real-time to a suitable Bluetooth communication device for forwarding it to a remote location and a certified medical professional capable of interpreting the results.
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K Number
K080047Device Name
CARDIOSEN'C
Manufacturer
SHL TELEMEDICINE INTERNATIONAL LTD.
Date Cleared
2008-07-11
(185 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
SHL TELEMEDICINE INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CardioSen'C device is intended to condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.
Device Description
The CardioSen'C is a personal, battery powered, hand-held personal ECG transmitter, enabling an individual to immediately transmit a 12-lead ECG and a rhythm strip from a remote location, to a physician's office, hospital or monitoring center. The ECG data can be transmitted in real time via two communication methods. The CardioSen'C produces an ECG frequency modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The ECG data can also be transmitted digitally through the cellular network. Either one of these two transmissions methods permits the transfer of a 12-lead ECG and rhythm strip to the medical professional capable of interpreting the data.
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K Number
K063609Device Name
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
Manufacturer
SHL TELEMEDICINE INTERNATIONAL LTD.
Date Cleared
2007-09-12
(282 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
SHL TELEMEDICINE INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The River-1 is indicated for the evaluation of patients who experience transient symptoms such as dizziness, palpitations, syncope, or chest pain that might suggest arrhythmia. The device is intended to record cardiac activity associated with those infrequent and transient symptoms. Once the data is recorded, the patient transmits this ECG data over the telephone or cellular network to a remote central receiving station to be reviewed by a healthcare professional.
Device Description
The River-1 is a patient activated electrocardiograph (ECG) symptomatic event recorder and transmitter. The River is a looping type ECG recording device (it records the ECG continuously). When the patient presses the ECG Record Button to record an ECG, the device stores both the recently recorded ECG and the ECG, following activation. The recorded ECG can then be transmitted to a healthcare facility or receiving center via two distinct channels: digitally via cellular network or acoustically via any phone.
The River-1 is a portable programmable device which is worn on the belt of the patient. It features a simple LCD screen, key pad, and is powered by a rechargeable battery. It can accommodate up to three leads for the option of recording 1, 2, or 3 lead ECG data.
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K Number
K003392Device Name
CARDIO MONITOR CENTER VISION; MODEL S-CV7-00
Manufacturer
SHL TELEMEDICINE INTERNATIONAL LTD.
Date Cleared
2001-01-25
(86 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
SHL TELEMEDICINE INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K981807Device Name
CARDIOVISION SOFTWARE, MODEL S-CV5-96
Manufacturer
SHL TELEMEDICINE INTERNATIONAL LTD.
Date Cleared
1998-08-19
(90 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
SHL TELEMEDICINE INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VISUALIZATION AND MEASUREMENT OF ECG BY TRAINED USED RECORDINGS TO BE MEDICAL CONDITION. MON | TORING CARDIAC IN THE OF STAFF
Device Description
The Cardio Vision software is a program which runs on a personal computer and is used for the display and storage of Electrocardiogram recordings. The software receives an input signal containing the ECG data from an ECG receiving center. The receiving center is connected to the computer on which the Cardio Vision software is running via a serial port. The ECG receiving center receives the ECG signal from an ECG recording device either via direct connection or via telephone. The software interprets the digital signal and displays it on the screen in real time as a single or multiple lead ECG plot.
The received ECG signal can be stored on the disk and can be compared to previous ECG recordings for that patient. In addition, measurements can be performed on the ECG plot.
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