BEUDAMED
    FDA Registration Active 🇺🇸 United States

    U22-1

    Reg #: 1450057 · FEI: 1450057 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Omron Healthcare, Inc.
    Registration Number
    1450057
    FEI Number
    1450057
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2895 Greenspoint Parkway
    City
    Hoffman Est
    State
    IL
    ZIP
    60169
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062263

    Owner / Operator

    Firm Name
    Omron Healthcare, Inc.
    Operator Number
    10023760
    Address
    2895 Greenspoint Parkway, Suite 100
    City
    Hoffman Estates
    State
    IL
    Postal Code
    60169
    Country
    US
    Correspondent
    Terri Ingalls

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF

    Proprietary Names

    U22-1 U22-3 U22-2 U22-4 U22-5 U100-3 NE-U100 U100-5 U100-4 U100-2 NE-U22V

    Establishment Types

    Repack or Relabel Medical Device