BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vision HDR

    Reg #: 2243057 · FEI: 2243057 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Accogent Pausch
    Registration Number
    2243057
    FEI Number
    2243057
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    808 Shrewsbury Ave
    City
    Tinton Falls
    State
    NJ
    ZIP
    07724
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081073

    Owner / Operator

    Firm Name
    PAUSCH LLC
    Operator Number
    2243057
    Address
    808 SHREWSBURY AVENUE, --
    City
    Eatontown
    State
    NJ
    Postal Code
    07724
    Country
    US

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    Vision HDR Uromat HD r/f HDR Vision Bladeview HDR HD r/f Bladevision HD r/f UROVISION HDR ACCOGENT SYS.

    Establishment Types

    Manufacture Medical Device