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FDA 510(k)

ActiGraph CentrePoint Insight Watch

K-Number: K181077 · 2018-05-24

ApplicantActigraph
Decision Date2018-05-24
Product CodeLEL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ActiGraph CentrePoint Insight Watch is a medical device manufactured by Actigraph. It received FDA 510(k) clearance on 2018-05-24 under approval number K181077. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ActiGraph CentrePoint Insight Watch?

ActiGraph CentrePoint Insight Watch is a medical device that received FDA 510(k) clearance on 2018-05-24. It is manufactured by Actigraph. The 510(k) number is K181077.

When was ActiGraph CentrePoint Insight Watch approved by the FDA?

ActiGraph CentrePoint Insight Watch received FDA 510(k) clearance on 2018-05-24, under approval number K181077.

What company makes ActiGraph CentrePoint Insight Watch?

ActiGraph CentrePoint Insight Watch is manufactured by Actigraph.

What is the FDA product code for ActiGraph CentrePoint Insight Watch?

The FDA product code for ActiGraph CentrePoint Insight Watch is LEL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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