ActiGraph CentrePoint Insight Watch— 510(k) K181077

Substantially Equivalent

Actigraph

FDA 510(k) clearance K181077 for ActiGraph CentrePoint Insight Watch, Substantially Equivalent on 2018-05-24. Applicant: Actigraph. Device class: 2.

Clearance details

Applicant
Actigraph
Product code
Code LEL
Device class
Class 2
Regulation
21 CFR 882.5050
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Pensacola, FL, US
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