BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SleepImage System

    Reg #: 3009498109 · FEI: 3009498109 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MYCARDIO
    Registration Number
    3009498109
    FEI Number
    3009498109
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3200 E Cherry Creek South Dr, Suite 540
    City
    Denver
    State
    CO
    ZIP
    80209
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182618

    Owner / Operator

    Firm Name
    MyCardio
    Operator Number
    10039503
    Address
    3200 E Cherry Creek South Dr, Suite 540
    City
    Denver
    State
    CO
    Postal Code
    80209
    Country
    US
    Correspondent
    Bogi Palsson

    Products

    Device Name Product Code
    Ventilatory Effort Recorder MNR

    Proprietary Names

    SleepImage System

    Establishment Types

    Manufacture Medical Device