Name: Predicase
Price: 199 USD

K-number	K090556
Device name	SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE
Applicant	Spacelabs Healthcare Medical Equipment (Suzhou) CO
Product code	MHX
Device class	Class II
Decision date	Apr 30, 2009
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE

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