Name: Predicase
Price: 199 USD

K-number	K141113
Device name	SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
Applicant	Spacelabs Healthcare, Ltd.
Product code	DXN
Device class	Class II
Decision date	Sep 26, 2014
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE

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