FDA 510(k)

SleepStageML

K-Number: K233438 · 2024-03-08

Decision Date2024-03-08

Product CodeOLZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SleepStageML is the device name listed in this FDA 510(k) record. The listed applicant is Beacon Biosignals, Inc.. It received FDA 510(k) clearance on 2024-03-08 under 510(k) 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. The listed applicant is Beacon Biosignals, Inc.. The 510(k) number is K233438.

When did SleepStageML receive FDA 510(k) clearance?

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

Who is the listed applicant for SleepStageML?

The FDA 510(k) record lists Beacon Biosignals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SleepStageML?

The FDA product code for SleepStageML is OLZ.

Other records listing Beacon Biosignals, Inc. as applicant

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.

K242094Dreem 3S K223539Dreem 3S

Related Devices (Code: OLZ)

K253390SOMNUM (SOMNUM)Honeynaps Co., Ltd.K253668Onera SleepMap (SLEEPMAP)Onera B.V.K250851Hypnos (369054-200)Cadwell Industries, Inc.K252330DeepRESPNox Medical Ehf K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC K241960DeepRESPNox Medical Ehf

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.