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510(k) K111618

AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION by Natus Medical Incorporated — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2011
Date Received
June 10, 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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