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510(k) K141446

ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, by Natus Medical Incorporated — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2014
Date Received
June 2, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
Review Panel
NE
Submission Type

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