K-number	K071889
Device name	DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
Applicant	GE Healthcare
Product code	DSI
Device class	Class II
Decision date	May 19, 2008
Decision	Substantially Equivalent
Regulation	870.1025

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View the full FDA submission: accessdata.fda.gov

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DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE

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