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510(k) K173936

Natus Photic Stimulator by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2018
Date Received
December 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Photic, Evoked Response
Device Class
Class II
Regulation Number
882.1890
Review Panel
NE
Submission Type

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