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510(k) K151509

GSI TympStar Pro Middle Ear Analyzer by Diagnostic Group, Dba Grason-Stadler — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2015
Date Received
June 4, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Tester, Auditory Impedance
Device Class
Class II
Regulation Number
874.1090
Review Panel
EN
Submission Type

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