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510(k) Data Aggregation
K Number
K113446Device Name
VIGNET TELEHEALTH MANAGER
Manufacturer
VIGNET INC.
Date Cleared
2012-07-16
(238 days)
Product Code
DRG, DXN, NBW
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
VIGNET INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vignet TeleHealth Manager is an accessory software application that is intended to be used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Vignet Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The Vignet TeleHealth Manager does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
Device Description
The Vignet TeleHealth Manager is a software system that collects patient physiological data such as blood pressure and blood sugar levels for transmission to a secure central storage server which can be accessed by health care professionals for analysis and intervention using standard digital communication technologies and protocols. This data is also available to the patient for viewing purposes and as an aid in maintaining wellness regimens.
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