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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automatic event detection software for polysomnograph with electroencephalograph
510(k) Number K173366
Device Name NicoletOne
Natus Neurology Incorporated
3150 Pleasant View Road
Middleteon,  WI  53562
Applicant Contact Shane T. Sawall
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton,  WI  53562
Correspondent Contact Martin A Dockter
Regulation Number882.1400
Classification Product Code
Subsequent Product Codes
Date Received10/26/2017
Decision Date 07/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No