BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Kosmos OTS Application

    Reg #: 3013757696 · FEI: 3013757696 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    ECHONOUS, INC.
    Registration Number
    3013757696
    FEI Number
    3013757696
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8310 154th Ave NE, Building B, Suite 200
    City
    Redmond
    State
    WA
    ZIP
    98052
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212100

    Owner / Operator

    Firm Name
    ECHONOUS, INC.
    Operator Number
    10055454
    Address
    8310 154th Ave NE, Building B, Suite 200
    City
    Redmond
    State
    WA
    Postal Code
    98052
    Country
    US
    Correspondent
    Joshua Kim

    Products

    Device Name Product Code
    Stethoscope, Electronic DQD
    Transducer, Ultrasonic, Diagnostic ITX
    Electrocardiograph DPS
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Kosmos OTS Application Kosmos Torso-One AI Station 2 Kosmos ECG Connector KOSMOS Kosmos Lexsa Kosmos Kosmos Binaural Headset Kosmos Platform Kosmos Torso-One – USB Kosmos Hub Kosmos Bridge Kosmos Torso Kosmos Power Pack

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device