K-number	K060150
Device name	SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
Applicant	Andante Medical Devices , Ltd.
Product code	IRN
Device class	Class II
Decision date	Feb 23, 2006
Decision	Substantially Equivalent
Regulation	890.5575

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View the full FDA submission: accessdata.fda.gov

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SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM

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