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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 the device name listed in this FDA 510(k) record. The listed applicant is Actigraph. It received FDA 510(k) clearance on 2018-05-24 under 510(k) 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. The listed applicant is Actigraph. The 510(k) number is K181077.

When did ActiGraph CentrePoint Insight Watch receive FDA 510(k) clearance?

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

Who is the listed applicant for ActiGraph CentrePoint Insight Watch?

The FDA 510(k) record lists Actigraph as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Actigraph as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231532ActiGraph LEAP activity monitor (ActiGraph LEAP)

Related Devices (Code: LEL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252981EmbraceMiniEmpatica S.r.l.K251574Sleep WatchAmbulatory Monitoring, Inc.K243513DCM (PW-DCM)Pneumowave, Ltd.K233987VERABAND™Arbor Medical Innovations, LLCK233618Oxevision Sleep DeviceOxehealth LimitedK231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC

Official Source

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

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