K-number	K160500
Device name	Elite SPK, Compasso, Elite SPK Kit
Applicant	Ncs Lab Srl
Product code	MBI
Device class	Class II
Decision date	Apr 20, 2016
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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Elite SPK, Compasso, Elite SPK Kit

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