Name: Predicase
Price: 199 USD

K-number	K220421
Device name	BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
Applicant	Apex BioTechnology Corp.
Product code	NBW
Device class	Class II
Decision date	Nov 4, 2022
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System

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