K-number	K033645
Device name	OTOFLEX 100 TYE 1012
Applicant	Gn Otometrics A/S
Product code	ETY
Device class	Class II
Decision date	Mar 31, 2004
Decision	Substantially Equivalent
Regulation	874.1090

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View the full FDA submission: accessdata.fda.gov

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OTOFLEX 100 TYE 1012

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