Name: Predicase
Price: 199 USD

K-number	K240640
Device name	Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
Applicant	Sejoy Biomedical Co., Ltd.
Product code	NBW
Device class	Class II
Decision date	Oct 8, 2024
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

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