K-number	K182286
Device name	Oh'Care Lite Smart Blood Glucose Monitoring System
Applicant	Osang Healthcare Co. , Ltd.
Product code	NBW
Device class	Class II
Decision date	Sep 19, 2018
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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Oh'Care Lite Smart Blood Glucose Monitoring System

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