Name: Predicase
Price: 199 USD

K-number	K022740
Device name	DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
Applicant	Datex-Ohmeda
Product code	MLD
Device class	Class II
Decision date	Nov 14, 2002
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE

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