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510(k) Data Aggregation
K Number
K163099Device Name
My Dose Coach
Manufacturer
Date Cleared
2017-03-22
(135 days)
Product Code
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
Sanofi, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
My Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. My Dose Coach is intended as an aid to the patient to provide dose suggestions based upon the HCP's independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient instructions. The application uses the dose plan instructions provided by the patient's HCP to provide dose suggestions of once-daily long-acting basal insulin titration) that are based on the patient's Fasting Blood Glucose ( FBG) as well as hypoglycemia occurrence.
My Dose Coach is not intended to replace the care or advice of a physician or HCP.
Device Description
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