Name: Predicase
Price: 199 USD

K-number	K150833
Device name	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System
Applicant	Andon Health Co, Ltd.
Product code	NBW
Device class	Class II
Decision date	Dec 4, 2015
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System

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