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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
49 E Chase St
pensacola,  FL  32502
Applicant Contact brian bell
49 E Chase St
pensacola,  FL  32502
Correspondent Contact brian bell
Regulation Number882.5050
Classification Product Code
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