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510(k) K112247

A BAER WITH ABAER I/O FUNCTION by Natus Medical Incorporated — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2012
Date Received
August 4, 2011
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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