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FDA 510(k)

SleepStageML

K-Number: K233438 · 2024-03-08

ApplicantBeacon Biosignals, Inc.
Decision Date2024-03-08
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SleepStageML is a medical device manufactured by Beacon Biosignals, Inc.. It received FDA 510(k) clearance on 2024-03-08 under approval number K233438. 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 SleepStageML?

SleepStageML is a medical device that received FDA 510(k) clearance on 2024-03-08. It is manufactured by Beacon Biosignals, Inc.. The 510(k) number is K233438.

When was SleepStageML approved by the FDA?

SleepStageML received FDA 510(k) clearance on 2024-03-08, under approval number K233438.

What company makes SleepStageML?

SleepStageML is manufactured by Beacon Biosignals, Inc..

What is the FDA product code for SleepStageML?

The FDA product code for SleepStageML is OLZ.

Other Devices by Beacon Biosignals, Inc.

K223539Dreem 3S K242094Dreem 3S

Related Devices (Code: OLZ)

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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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