Name: Predicase
Price: 199 USD

K-number	K021955
Device name	TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
Applicant	Datex-Ohmeda, Inc.
Product code	DQA
Device class	Class II
Decision date	Oct 8, 2002
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES

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