Report Studio— 510(k) K261747

Substantially Equivalent

Beacon Biosignals, Inc.

FDA 510(k) clearance K261747 for Report Studio, Substantially Equivalent on 2026-08-25. Applicant: Beacon Biosignals, Inc.. Device class: 2.

Clearance details

Applicant: Beacon Biosignals, Inc.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2026-05-27
Decision date: 2026-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLV

K260585 — Noxturnal Web2026-03-20
K242447 — Falcon HST2025-02-20
K241288 — Noxturnal Web2024-12-23
K240700 — HomeSleepTest (HST, HST REM+)2024-12-08
K213007 — Cerebra Sleep System2022-07-06

More clearances from Beacon Biosignals, Inc.

Data sourced from openFDA. This site is unofficial and independent of the FDA.