Report Studio— 510(k) K261747
Substantially EquivalentBeacon Biosignals, Inc.
FDA 510(k) clearance K261747 for Report Studio, Substantially Equivalent on 2026-08-25. Applicant: Beacon Biosignals, Inc.. Device class: 2.
Summary
Beacon Biosignals' Report Studio is filed under product code OLV, standard polysomnographs with electroencephalograph. The record doesn't describe the product beyond its name and that code.
Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Beacon Biosignals filed from Boston, Massachusetts. The decision came 90 calendar days after receipt (May 27 to August 25, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Beacon Biosignals, Inc.
- Product code
- Product code OLV
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code OLV
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