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510(k) Data Aggregation
K Number
K092635Device Name
ALCATEL-LUCENT TELEHEATH MANAGER
Manufacturer
ALCATEL-LUCENT CANADA INC.
Date Cleared
2009-09-10
(14 days)
Product Code
DRG, DXN, NBW
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
ALCATEL-LUCENT CANADA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Alcatel-Lucent TeleHealth Manager is a Remote Patient Monitoring solution intended to provide monitoring services of patient vital signs and other physiological data by remote data transmission from a patient to the practitioner.
The system can be used by patients during their daily lives and allows the collection, recording and transmission of physiological information such as blood glucose levels, using a glucometer, and non-invasive blood pressure measurements.
The transmission of data to a secure server hosting platform is carried out over existing telecommunications infrastructure via common telephone lines and mobile networks. The data is collected in a secure server hosting platform, which stores the information and allows its remote access by the patient and/or health care professional.
Alcatel-Lucent TeleHealth Manager is intended as an aid for the continuous monitoring of physiological processes and is not intended as a replacement of the medical oversight of a trained healthcare professional.
Device Description
Alcatel-Lucent TeleHealth Manager is a software system that collects patient physiological data such as blood pressure and blood sugar levels, via Bluetooth technology combined with cellular or plain old telephone system (POTS) home access point, for transmission to a secure central storage server which can be accessed by health care professionals for analysis and intervention. This data is also available to the patient for viewing purposes and as an aid in the self management of their specific health condition.
As Alcatel-Lucent TeleHealth Manager main function is to relay a reading to the appropriate users without alteration or post processing of the measurement, it is the responsibility of the patient-user to verify that the reading has been correctly executed.
With respect to patient data privacy, patient data is encrypted by the Alcatel-Lucent TeleHealth Manager system in such a way that it can be securely accessed only by the authorized users.
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