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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K172743
Device Name Natus VikingQuest
Applicant
Natus Neurology Incorporated
3150 Pleasant View Rd.
Middleton,  WI  53562
Applicant Contact Shane T. Sawall
Correspondent
Natus Neurology Incorporated
3150 Pleasant View Rd.
Middleton,  WI  53562
Correspondent Contact Shane T. Sawall
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Codes
GWE   GWF   GWJ   GZP   JXE  
OLT  
Date Received09/12/2017
Decision Date 12/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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