K-number	K031051
Device name	SMARTEP-ASSR, MODEL M811007
Applicant	Intelligent Hearing Systems
Product code	GWJ
Device class	Class II
Decision date	Feb 20, 2004
Decision	Substantially Equivalent
Regulation	882.1900

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View the full FDA submission: accessdata.fda.gov

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SMARTEP-ASSR, MODEL M811007

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