FDA 510(k)

Dreem 3S

K-Number: K223539 · 2023-08-18

Decision Date2023-08-18

Product CodeOLZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Dreem 3S 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 2023-08-18 under 510(k) 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. The listed applicant is Beacon Biosignals, Inc.. The 510(k) number is K223539.

When did Dreem 3S receive FDA 510(k) clearance?

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

Who is the listed applicant for Dreem 3S?

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 Dreem 3S?

The FDA product code for Dreem 3S 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 K233438SleepStageML

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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.