Name: Predicase
Price: 199 USD

K-number	K102678
Device name	ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
Applicant	Andon Medical Co., Ltd.
Product code	NBW
Device class	Class II
Decision date	Aug 26, 2011
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS

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