Name: Predicase
Price: 199 USD

K-number	K190564
Device name	Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
Applicant	Bionime Corporation
Product code	NBW
Device class	Class II
Decision date	Jun 2, 2019
Decision	Substantially Equivalent
Regulation	862.1345

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB

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