FDA 510(k)

ActTrust

K-Number: K151784 · 2016-05-25

Decision Date2016-05-25

Product CodeLEL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ActTrust is the device name listed in this FDA 510(k) record. The listed applicant is Condor Instruments Ltda. - Epp. It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K151784. 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 ActTrust?

ActTrust is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Condor Instruments Ltda. - Epp. The 510(k) number is K151784.

When did ActTrust receive FDA 510(k) clearance?

ActTrust received FDA 510(k) clearance on 2016-05-25, under 510(k) number K151784.

Who is the listed applicant for ActTrust?

The FDA 510(k) record lists Condor Instruments Ltda. - Epp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ActTrust?

The FDA product code for ActTrust is LEL.

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, LLC K233618Oxevision Sleep DeviceOxehealth Limited K231532ActiGraph 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.