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510(k) K152301

Background Pattern Classification [BPc(TM)] by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) — Product Code OMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2016
Date Received
August 14, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplitude-Integrated Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).

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