K-number	K925648
Device name	SMART-SCREENER (AUDITORY)
Applicant	Intelligent Hearing Systems
Product code	GWJ
Device class	Class II
Decision date	May 11, 1993
Decision	Substantially Equivalent
Regulation	882.1900

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View the full FDA submission: accessdata.fda.gov

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SMART-SCREENER (AUDITORY)

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