Name: Predicase
Price: 199 USD

K-number	K011670
Device name	DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
Applicant	Datex-Ohmeda
Product code	DQA
Device class	Class II
Decision date	Jun 26, 2001
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE

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