Name: Predicase
Price: 199 USD

K-number	K043276
Device name	DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
Applicant	Datex-Ohmeda
Product code	MHX
Device class	Class II
Decision date	Dec 23, 2004
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/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE

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