Name: Predicase
Price: 199 USD

K-number	K051217
Device name	DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)
Applicant	GE Healthcare
Product code	MHX
Device class	Class II
Decision date	Feb 3, 2006
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 PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)

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