Name: Predicase
Price: 199 USD

K-number	K061822
Device name	OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
Applicant	Omron Healthcare, Inc.
Product code	DXN
Device class	Class II
Decision date	Aug 2, 2006
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3

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