K-number	K181070
Device name	iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
Applicant	Andon Health Co, Ltd.
Product code	NBW
Device class	Class II
Decision date	Feb 1, 2019
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

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