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510(k) K242094

Dreem 3S by Beacon Biosignals, Inc. — Product Code OLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2024
Date Received
July 17, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user

Other clearances by Beacon Biosignals, Inc.

  • K233438 — SleepStageML (March 8, 2024)
  • K223539 — Dreem 3S (August 18, 2023)

Other clearances for product code OLZ

  • K253668 — Onera SleepMap (SLEEPMAP) (March 8, 2026)
  • K250851 — Hypnos (369054-200) (December 14, 2025)
  • K252330 — DeepRESP (November 17, 2025)
  • K250058 — NEAT 001 (April 10, 2025)
  • K241960 — DeepRESP (March 14, 2025)
  • K233438 — SleepStageML (March 8, 2024)
  • K223539 — Dreem 3S (August 18, 2023)
  • K223922 — SOMNUM (V.1.1.2.) (August 16, 2023)
  • K221179 — SomnoMetry (September 21, 2022)
  • K210034 — EnsoSleep (June 16, 2021)