BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HBT SLEUTH

    Reg #: 3004141536 · FEI: 3004141536 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BREATHE E-Z SYSTEMS, INC.
    Registration Number
    3004141536
    FEI Number
    3004141536
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12702, CHEROKEE LN
    City
    LEAWOOD
    State
    KS
    ZIP
    66209
    Country
    US

    Regulatory Submissions

    510(k) Number
    K874892

    Owner / Operator

    Firm Name
    BREATHE E-Z SYSTEMS, INC.
    Operator Number
    9058422
    Address
    12702 CHEROKEE LN., --
    City
    Leawood
    State
    KS
    Postal Code
    66209
    Country
    US
    Correspondent
    DOUGLAS W DAHL

    Products

    Device Name Product Code
    System, Breath Measurement NRH

    Proprietary Names

    HBT SLEUTH

    Establishment Types

    Manufacture Medical Device