BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sleep Scout

    Reg #: 1530224 · FEI: 3000206198 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Beacon Bio Dx, LLC dba CleveMed
    Registration Number
    1530224
    FEI Number
    3000206198
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4415 Euclid Avenue, Ste # 400
    City
    CLEVELAND
    State
    OH
    ZIP
    44103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042039

    Owner / Operator

    Firm Name
    Beacon Bio Dx,LLC dba CleveMed
    Operator Number
    9023591
    Address
    4415 EUCLID AVE., --
    City
    Cleveland
    State
    OH
    Postal Code
    44103
    Country
    US

    Products

    Device Name Product Code
    Full-Montage Standard Electroencephalograph GWQ
    Standard Polysomnograph With Electroencephalograph OLV

    Proprietary Names

    Sleep Scout Sapphire PSG SleepView

    Establishment Types

    Manufacture Medical Device