Cleared Special

ActiGraph CentrePoint Insight Watch

K181077 · Actigraph · Neurology
May 2018
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K181077 is an FDA 510(k) clearance for the ActiGraph CentrePoint Insight Watch, a Device, Sleep Assessment (Class II — Special Controls, product code LEL), submitted by Actigraph (Pensacola, US). The FDA issued a Cleared decision on May 24, 2018, 30 days after receiving the submission on April 24, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K181077 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2018
Decision Date May 24, 2018
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code LEL — Device, Sleep Assessment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050