BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Waveband

    Reg #: 3027726372 · FEI: 3027726372 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BEACON BIOSIGNALS, INC.
    Registration Number
    3027726372
    FEI Number
    3027726372
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    22 Boston Wharf Rd Fl 7 Unit 41
    City
    Boston
    State
    MA
    ZIP
    02210
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223539

    Owner / Operator

    Firm Name
    Beacon Biosignals, Inc.
    Operator Number
    10088399
    Address
    22 Boston Wharf Rd., 7th Floor, Unit 41
    City
    Boston
    State
    MA
    Postal Code
    02210
    Country
    US
    Correspondent
    Leticia Soto

    Products

    Device Name Product Code
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Standard Polysomnograph With Electroencephalograph OLV

    Proprietary Names

    Waveband Dreem 3 System

    Establishment Types

    Manufacture Medical Device