BEACON BIOSIGNALS, INC.

FDA Device Registration & Listing · Boston, MA, US · Registration 3027726372

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027726372
FEI Number
3027726372
Entity Name
BEACON BIOSIGNALS, INC.
City/State/Country
Boston, MA, US
Establishment Address
22 Boston Wharf Rd Fl 7 Unit 41, Boston, MA 02210, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Beacon Biosignals, Inc. (Owner Number: 10088399)
Owner / Operator Contact Address
22 Boston Wharf Rd., 7th Floor, Unit 41, Boston, MA 02210, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K223539
PMA Number
N/A

All Registered Proprietary Names

Waveband Dreem 3 System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2023-11-10
OLV Standard Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2023-11-10

Official Correspondent

Leticia Soto

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Beacon Biosignals, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K161650 Neurotronics, Inc. Polysmith Sleep System, Model NTI7593 2017-01-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027726372. Last updated year: 2026. Please use registration number 3027726372 when referencing this establishment in official correspondence.
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