BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DRE Waveline EZ-Max V2 Monitor

    Reg #: 1000122786 · FEI: 1000122786 · Expires 2025
    View on FDA
    Products
    14
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    14

    Registration Details

    Registration Name
    DRE Med
    Registration Number
    1000122786
    FEI Number
    1000122786
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2601 Stanley Gault PKWY
    City
    Louisville
    State
    KY
    ZIP
    40223
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131971

    Owner / Operator

    Firm Name
    DRE Resume LLC
    Operator Number
    10092249
    Address
    2601 Stanley Gault Pkwy, STE 101
    City
    Louisville
    State
    KY
    Postal Code
    40223
    Country
    US
    Correspondent
    Carlos Borges

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Computer, Blood-Pressure DSK
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Detector And Alarm, Arrhythmia DSI
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Oximeter DQA
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Continuous Measurement Thermometer FLL
    Monitor, St Segment With Alarm MLD

    Proprietary Names

    DRE Waveline EZ-Max V2 Monitor

    Establishment Types

    Repack or Relabel Medical Device