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510(k) Data Aggregation
K Number
K051544Device Name
VITALCAREGIVING SYSTEM
Manufacturer
ADVANCED MONITORING CAREGIVING INC.
Date Cleared
2005-10-07
(119 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED MONITORING CAREGIVING INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMC SYSTEM is indicated when a physician wants to periodically measure data of chronically-ill home r nt reason it me monitoring devices connected via wired or wireless facilities to a central station, where parts can be generated and viewed via a Web browser by authorized personnel (e.g. physicians, care givers, and patients). The system is not intended to provide real-time data or real-time monitoring.
Device Description
The AMC System receives data from cleared home measurement devices via an intermediary organization, stores the information in databases, and produces reports for patients and physicians that can be viewed on the Internet by means of secure transmission methods. The AMC system has no direct interface with patients or patients' measuring devices.
The AMC system performs no diagnosis. It stores the received data in the patient's file as received from intermediate organizations, and generates reports in the form of diagrams, data sheets, histograms and scatter diagrams (where applicable).
The AMC system allows the patient and his doctor to access the patient's data via the Internet by use of secured password-protected access codes. These codes (User name and password) are assigned by the AMC system ..
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