Beacon Biosignals, Inc. is one of 16067 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Beacon Biosignals, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Report Studio, Dreem 3S, SleepStageML
4
Total
4
Cleared
0
Denied
Beacon Biosignals, Inc. has 4 FDA 510(k) cleared medical devices. Based in Boston, US.
Latest FDA clearance: Aug 2026. Active since 2023. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Beacon Biosignals, Inc. Filter by specialty or product code using the sidebar.
1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Beacon Biosignals, Inc.
4 devices