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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K243982
Device Name Nicolet EDX
Applicant
Natus Neurology Incorporated
3150 Pleasant View Rd.
Middleton,  WI  53562
Applicant Contact Judy Samson
Correspondent
Natus Neurology Incorporated
3150 Pleasant View Rd.
Middleton,  WI  53562
Correspondent Contact Judy Samson
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWE   GWJ   GZP   IKN   JXE  
OLT  
Date Received12/23/2024
Decision Date 01/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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