K-number	K110286
Device name	GN OTOMETRICS TYPE 1053 FREEFIT
Applicant	Gn Otometrics A/S
Product code	ETW
Device class	Class II
Decision date	Apr 28, 2011
Decision	Substantially Equivalent
Regulation	874.3310

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View the full FDA submission: accessdata.fda.gov

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GN OTOMETRICS TYPE 1053 FREEFIT

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