Name: Predicase
Price: 199 USD

K-number	K050233
Device name	OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI
Applicant	Omron Healthcare, Inc.
Product code	DXN
Device class	Class II
Decision date	Oct 28, 2005
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI

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