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FDA 510(k)

Dreem 3S

K-Number: K223539 · 2023-08-18

ApplicantBeacon Biosignals, Inc.
Decision Date2023-08-18
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Dreem 3S is a medical device manufactured by Beacon Biosignals, Inc.. It received FDA 510(k) clearance on 2023-08-18 under approval number K223539. 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 Dreem 3S?

Dreem 3S is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Beacon Biosignals, Inc.. The 510(k) number is K223539.

When was Dreem 3S approved by the FDA?

Dreem 3S received FDA 510(k) clearance on 2023-08-18, under approval number K223539.

What company makes Dreem 3S?

Dreem 3S is manufactured by Beacon Biosignals, Inc..

What is the FDA product code for Dreem 3S?

The FDA product code for Dreem 3S is OLZ.

Other Devices by Beacon Biosignals, Inc.

K242094Dreem 3S K233438SleepStageML

Related Devices (Code: OLZ)

K162140RemLogicEmbla Systems K153353SANDMAN ELITEEmbla Systems K153412Sleep ProfilerAdvanced Brain Monitoring, Inc. K163617REMbrandtEmbla Systems K162627EnsoSleepEnsodata, Inc. K173366NicoletOneNatus Neurology Incorporated

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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