Name: Predicase
Price: 199 USD

K-number	K162225
Device name	WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
Applicant	Welldoc, Inc.
Product code	MRZ
Device class	Class II
Decision date	Nov 22, 2016
Decision	Substantially Equivalent
Regulation	880.5725

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

Everything you need for a 510(k) submission. Nothing you don't.