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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 K261521
Device Name Sleep Analysis Module
Applicant
Neurotronics, LLC
13800 Tech City Cir., Suite 400
Alachua,  FL  32615
Applicant Contact James Smith
Correspondent
Neurotronics, LLC
13800 Tech City Cir., Suite 400
Alachua,  FL  32615
Correspondent Contact James Smith
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received05/07/2026
Decision Date 10/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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