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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Effort Belt For Polysomnography
510(k) Number K251480
Device Name PV01 PVDF Effort Sensor
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
SFK  
Date Received05/13/2025
Decision Date 08/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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