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510(k) K162210

touchTymp by Maico Diagnostics GmbH — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2016
Date Received
August 5, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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