BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Innova IGS

    Reg #: 3007556128 · FEI: 3007556128 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Grand Medical Equipment, Inc.
    Registration Number
    3007556128
    FEI Number
    3007556128
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3 Corporate Dr
    City
    Cranbury
    State
    NJ
    ZIP
    08512
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181403

    Owner / Operator

    Firm Name
    Grand Medical Equipment, Inc.
    Operator Number
    10034205
    Address
    3 Corporate Drive
    City
    Cranbury
    State
    NJ
    Postal Code
    08512
    Country
    US
    Correspondent
    Sean Chen

    Products

    Device Name Product Code
    System, X-Ray, Angiographic IZI
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB

    Proprietary Names

    Innova IGS

    Establishment Types

    Repack or Relabel Medical Device