BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UroVista 5.1 Bladder Scan

    Reg #: 3020710391 · FEI: 3020710391 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    EXODUS SCIENTIFIC LLC
    Registration Number
    3020710391
    FEI Number
    3020710391
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    515 North Flagler Drive, Suite P-300
    City
    West Palm Beach
    State
    FL
    ZIP
    33401
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191307

    Owner / Operator

    Firm Name
    Exodus Scientific LLC
    Operator Number
    10083263
    Address
    515 North Flagler Drive, Suite 350
    City
    West Palm Beach
    State
    FL
    Postal Code
    33401
    Country
    US
    Correspondent
    Paula Reed

    Products

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

    Proprietary Names

    UroVista 5.1 Bladder Scan

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device