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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 K181077
Device Name ActiGraph CentrePoint Insight Watch
Applicant
ActiGraph
49 E Chase St
Pensacola,  FL  32502
Applicant Contact Brian Bell
Correspondent
ActiGraph
49 E Chase St
Pensacola,  FL  32502
Correspondent Contact Brian Bell
Regulation Number882.5050
Classification Product Code
LEL  
Date Received04/24/2018
Decision Date 05/24/2018
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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