K-number	K131660
Device name	SMART (SMART-D, SMART-DX)
Applicant	Bts S.P.A.
Product code	LXJ
Device class	Class II
Decision date	Apr 17, 2014
Decision	Substantially Equivalent
Regulation	890.5360

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View the full FDA submission: accessdata.fda.gov

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SMART (SMART-D, SMART-DX)

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