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510(k) K141524

NEURO-AUDIO by Teleemg, LLC USA — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2015
Date Received
June 9, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
Submission Type

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