BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VioScan L2, C7 Portable Ultrasound

    Reg #: 1066427 · FEI: 3007513035 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INFINIUM MEDICAL, INC.
    Registration Number
    1066427
    FEI Number
    3007513035
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12151 62ND ST., N,, UNIT 5
    City
    Largo
    State
    FL
    ZIP
    33773
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241161

    Owner / Operator

    Firm Name
    INFINIUM MEDICAL, INC.
    Operator Number
    10028895
    Address
    12151 62ND ST N, UNIT 5
    City
    Largo
    State
    FL
    Postal Code
    33773
    Country
    US
    Correspondent
    Oz Ozkaya

    Products

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

    Proprietary Names

    VioScan L2, C7 Portable Ultrasound

    Establishment Types

    Repack or Relabel Medical Device