Chrysalis Intelligence · Sponsors · Beacon Biosignals, Inc.

Beacon Biosignals, Inc.

Boston, MA, US · 4 510(k) clearances

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Total clearances
4
2023-08-18 → 2026-08-25
Last 12 months
1
Product codes
2
Most recent
2026-08-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph Class II Neurology 3 2024-11-22
OLV Standard Polysomnograph With Electroencephalograph Class II Neurology 1 2026-08-25
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2026-08-25 K261747 Report Studio OLV Class II Neurology
2024-11-22 K242094 Dreem 3S OLZ Class II Neurology
2024-03-08 K233438 SleepStageML OLZ Class II Neurology
2023-08-18 K223539 Dreem 3S OLZ Class II Neurology
Data source: openFDA · Generated 2026-09-08 09:57 · Last ingest 2026-09-08T13:56:10.065722 · Pipeline: Chrysalis Intelligence