ActiGraph CentrePoint Insight Watch

FDA 510(k) K181077 · Actigraph

Substantially Equivalent

510(k) numberK181077

Submission

Device name
ActiGraph CentrePoint Insight Watch
Applicant
Actigraph
Pensacola, FL, US
Received
April 24, 2018
Decision date
May 24, 2018
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LEL – Device, Sleep Assessment
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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Questions and answers

When was ActiGraph CentrePoint Insight Watch cleared by the FDA?

ActiGraph CentrePoint Insight Watch (K181077) received a 510(k) decision of Substantially Equivalent on May 24, 2018, 30 days after the submission was received.

What is the product code of K181077?

The FDA product code is LEL – Device, Sleep Assessment, a Class II (moderate risk) device regulated under 21 CFR 882.5050.