K-number	K132957
Device name	MADSEN ACCUSCREEN TYPE 1077
Applicant	Gn Otometrics
Product code	GWJ
Device class	Class II
Decision date	Feb 27, 2014
Decision	Substantially Equivalent
Regulation	882.1900

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View the full FDA submission: accessdata.fda.gov

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MADSEN ACCUSCREEN TYPE 1077

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