510(k) K181077

ActiGraph CentrePoint Insight Watch by Actigraph — Product Code LEL

K181077 is an FDA 510(k) premarket notification submitted by Actigraph for the device "ActiGraph CentrePoint Insight Watch". The FDA issued a decision of Substantially Equivalent on May 24, 2018. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050. Actigraph has at least 2 other 510(k) clearances on record.