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510(k) Data Aggregation
K Number
K071713Device Name
CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
Manufacturer
Date Cleared
2007-10-12
(112 days)
Product Code
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DECISIONS NETWORK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MDN-CGS™ Insulin Dosing Calculator is intended to evaluate the current patient blood glucose values. Based on the measurements, the software will calculate either a dose of glucose or insulin to drive the blood glucose level up or down toward a predetermined target range. Once that target blood glucose range has been reached, the software program calculates dosing of insulin or glucose for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing calculations of glucose or insulin. The device is intended for use with patients with no known insulin allergies and for patients over the age of 18.
The MDN-CGS™ Insulin Dosing Calculator programmed logic is a tool and not a substitute for, but rather an assist to, clinical reasoning. The measurements and calculations generated by the MDN-CGS™ Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel directed by physician order. No medical decisions are to be made solely on the guidance provided by this software program, but are to include consideration of clinical history, symptoms, other diagnostic measurements, and the professional's clinical judgment.
Device Description
The MDN-CGS ™ Insulin Dosing Calculator is a web-based software solution that automates calculations used by healthcare professionals to determine the appropriate intravenous insulin drip rate necessary to manage blood glucose levels across a variety of patient populations. The MDN-CGSTM Insulin Dosing Calculator also provides alerts for subsequent blood glucose testing and monitoring.
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