Name: Predicase
Price: 199 USD

K-number	K151978
Device name	EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
Applicant	Edan Instruments, Inc.
Product code	CHL
Device class	Class II
Decision date	Jul 15, 2016
Decision	Substantially Equivalent
Regulation	862.1120

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Source

View the full FDA submission: accessdata.fda.gov

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EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control

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