BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SonicEye® Dual-Array Ultrasound System

    Reg #: 3009565060 · FEI: 3009565060 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Sonivate Medical, Inc.
    Registration Number
    3009565060
    FEI Number
    3009565060
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4640 S Macadam Ave Ste 200
    City
    Portland
    State
    OR
    ZIP
    97239
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192253

    Owner / Operator

    Firm Name
    Sonivate Medical, Inc.
    Operator Number
    10040499
    Address
    4640 S Macadam Avenue, Suite 130B
    City
    Portland
    State
    OR
    Postal Code
    97239
    Country
    US

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    SonicEye® Dual-Array Ultrasound System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility