Name: Predicase
Price: 199 USD

K-number	K080501
Device name	SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240
Applicant	Taidoc Technology Corporation
Product code	NBW
Device class	Class II
Decision date	Apr 21, 2008
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240

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