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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sleep Assessment
510(k) Number K231532
Device Name ActiGraph LEAP activity monitor (ActiGraph LEAP)
Applicant
ActiGraph, LLC
70 North Baylen Street, Suite 400
Pensacola,  FL  32504
Applicant Contact Brian Bell
Correspondent
ActiGraph, LLC
70 North Baylen Street, Suite 400
Pensacola,  FL  32504
Correspondent Contact Brian Bell
Regulation Number882.5050
Classification Product Code
LEL  
Date Received05/26/2023
Decision Date 06/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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