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FDA 510(k)

REMbrandt

K-Number: K163617 · 2017-04-11

ApplicantEmbla Systems
Decision Date2017-04-11
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REMbrandt is a medical device manufactured by Embla Systems. It received FDA 510(k) clearance on 2017-04-11 under approval number K163617. 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 REMbrandt?

REMbrandt is a medical device that received FDA 510(k) clearance on 2017-04-11. It is manufactured by Embla Systems. The 510(k) number is K163617.

When was REMbrandt approved by the FDA?

REMbrandt received FDA 510(k) clearance on 2017-04-11, under approval number K163617.

What company makes REMbrandt?

REMbrandt is manufactured by Embla Systems.

What is the FDA product code for REMbrandt?

The FDA product code for REMbrandt is OLZ.

Other Devices by Embla Systems

K162140RemLogic K153353SANDMAN ELITE K172703Disposable Snap Electrode 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)

K162140RemLogicEmbla Systems K153353SANDMAN ELITEEmbla Systems K153412Sleep ProfilerAdvanced Brain Monitoring, Inc. 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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