BEUDAMED
    FDA Registration Active 🇺🇸 United States

    WaterCheck RC; WaterCheck CP; WaterCheck 2; RenalCheck PX

    Reg #: 3029754060 · FEI: 3029754060 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IBT Scientific
    Registration Number
    3029754060
    FEI Number
    3029754060
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1178 Telecom Drive
    City
    Creedmoor
    State
    NC
    ZIP
    27522
    Country
    US

    Regulatory Submissions

    510(k) Number
    K953854

    Owner / Operator

    Firm Name
    IBT Scientific LLC
    Operator Number
    10083938
    Address
    2931 Moose Trail
    City
    Elkhart
    State
    IN
    Postal Code
    46514
    Country
    US

    Products

    Device Name Product Code
    System, Dialysate Delivery, Single Patient FKP

    Proprietary Names

    WaterCheck RC; WaterCheck CP; WaterCheck 2; RenalCheck PX

    Establishment Types

    Manufacture Medical Device