K-number	K151509
Device name	GSI TympStar Pro Middle Ear Analyzer
Applicant	Diagnostic Group, Dba Grason-Stadler
Product code	ETY
Device class	Class II
Decision date	Jun 25, 2015
Decision	Substantially Equivalent
Regulation	874.1090

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Source

View the full FDA submission: accessdata.fda.gov

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GSI TympStar Pro Middle Ear Analyzer

Everything you need for a 510(k) submission. Nothing you don't.