BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cardiac Monitor 1500

    Reg #: 3022317389 · FEI: 3022317389 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ZYNEX MEDICAL, INC.
    Registration Number
    3022317389
    FEI Number
    3022317389
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3133 Indian Rd, Suite K
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191697

    Owner / Operator

    Firm Name
    ZYNEX MEDICAL, INC.
    Operator Number
    9028838
    Address
    9655 Maroon Circle
    City
    Englewood
    State
    CO
    Postal Code
    80112
    Country
    US

    Products

    Device Name Product Code
    Oximeter DQA
    Continuous Measurement Thermometer FLL
    Plethysmograph, Impedance DSB

    Proprietary Names

    Cardiac Monitor 1500 CM-1500

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility