Data / Medical devices / United States / Beacon Biosignals, Inc.
Beacon Biosignals, Inc.: FDA-registered device maker in Boston, MA, United States, 3 510(k) clearances
Beacon Biosignals, Inc. is registered with the FDA (registration 3027726372) in Boston, MA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 25, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027726372
- Address
- 22 Boston Wharf Rd Fl 7 Unit 41, Boston, MA, United States, 02210
- Owner or operator
- Beacon Biosignals, Inc. (10088399)
- Roles
- Manufacturer
- First device listed
- November 10, 2023
- Registered through
- 2027
- Brand names listed
- Report Studio, Waveband, Waveband Predetermined Change Control Plan (PCCP)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | 2 | Manufacturer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 25, 2026 | K261747 | Report Studio | OLV | Substantially Equivalent | Beacon Biosignals, Inc. | accessdata.fda.gov |
| November 22, 2024 | K242094 | Dreem 3S | OLZ | Substantially Equivalent | Beacon Biosignals, Inc. | accessdata.fda.gov |
| August 18, 2023 | K223539 | Dreem 3S | OLZ | Substantially Equivalent | Beacon Biosignals, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- All makers of Standard Polysomnograph With Electroencephalograph
Updated August 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.