Name: Predicase
Price: 199 USD

K-number	K060315
Device name	HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
Applicant	Healthstats International Pte. , Ltd.
Product code	DXN
Device class	Class II
Decision date	Apr 7, 2006
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM

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