BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MicrO2 Sleep Device with MicroRecorder

    Reg #: 3013116677 · FEI: 3013116677 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PROSOMNUS SLEEP TECHNOLOGIES
    Registration Number
    3013116677
    FEI Number
    3013116677
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5675 Gibraltar Drive
    City
    Pleasanton
    State
    CA
    ZIP
    94588
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161624

    Owner / Operator

    Firm Name
    ProSomnus Sleep Technologies
    Operator Number
    10053490
    Address
    5675 Gibraltar Drive
    City
    Pleasanton
    State
    CA
    Postal Code
    94588
    Country
    US
    Correspondent
    Divya Mavalli

    Products

    Device Name Product Code
    Sleep Appliances With Patient Monitoring PLC

    Proprietary Names

    MicrO2 Sleep Device with MicroRecorder Prosomnus [IA] Sleep Device with MicroRecorder

    Establishment Types

    Manufacture Medical Device