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FDA 510(k)

RemLogic

K-Number: K162140 · 2016-12-01

ApplicantEmbla Systems
Decision Date2016-12-01
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RemLogic is a medical device manufactured by Embla Systems. It received FDA 510(k) clearance on 2016-12-01 under approval number K162140. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RemLogic?

RemLogic is a medical device that received FDA 510(k) clearance on 2016-12-01. It is manufactured by Embla Systems. The 510(k) number is K162140.

When was RemLogic approved by the FDA?

RemLogic received FDA 510(k) clearance on 2016-12-01, under approval number K162140.

What company makes RemLogic?

RemLogic is manufactured by Embla Systems.

What is the FDA product code for RemLogic?

The FDA product code for RemLogic is OLZ.

Other Devices by Embla Systems

K153353SANDMAN ELITE K172703Disposable Snap Electrode K163617REMbrandt K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant K173793XactTrace Single Use Respiratory Effort Belt System

Related Devices (Code: OLZ)

K153353SANDMAN ELITEEmbla Systems K153412Sleep ProfilerAdvanced Brain Monitoring, Inc. K163617REMbrandtEmbla Systems K162627EnsoSleepEnsodata, Inc. K173366NicoletOneNatus Neurology Incorporated K192469Nox Sleep SystemNox Medical

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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