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510(k) Data Aggregation
K Number
K101806Device Name
AIDERA DIASEND SYSTEM
Manufacturer
AIDERA AB
Date Cleared
2010-12-07
(162 days)
Product Code
MRZ, NBW
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
AIDERA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aidera Diasend is indicated for use by individuals or healthcare professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.
Device Description
Diasend is a system for transmitting data from patients' home monitoring devices and consists of a transmitter, a server database and a website available for the care provider and the patient. The software transmitter is a Diasend software concept developed by Aidera that may run on a computer device, e.g. desktop computer, laptop or mobile phone, designed to transmit data to the Diasend server database. Current implementation is on Windows XP.
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K Number
K083221Device Name
AIDERA DIASEND
Manufacturer
AIDERA AB
Date Cleared
2009-02-03
(95 days)
Product Code
MRZ, NBW
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
AIDERA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diasend is intended for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server data base.
Device Description
Diasend is a system for transmitting of data from patients home monitoring devices and consists of a transmitter, a server database and a website available for the care provider and the patient.
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