K-number	K150691
Device name	Datalys Multi-Parameter Patient Monitor
Applicant	Lutech Industries, Inc.
Product code	MWI
Device class	Class II
Decision date	May 15, 2015
Decision	Substantially Equivalent
Regulation	870.2300

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View the full FDA submission: accessdata.fda.gov

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Datalys Multi-Parameter Patient Monitor

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