BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Omni II

    Reg #: 1066427 · FEI: 3007513035 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    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
    K103737

    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
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    Omni II Omni II K

    Establishment Types

    Manufacture Medical Device