BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zmachine DT-300; Zmachine Synergy

    Reg #: 1529102 · FEI: 1000160007 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Mirac, LLC
    Registration Number
    1529102
    FEI Number
    1000160007
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2153 WINNERS CIRCLE
    City
    DAYTON
    State
    OH
    ZIP
    45404
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172986

    Owner / Operator

    Firm Name
    Mirac, LLC
    Operator Number
    10079089
    Address
    2153 Winners Circle
    City
    Dayton
    State
    OH
    Postal Code
    45404
    Country
    US
    Correspondent
    Matthew Brown

    Products

    Device Name Product Code
    Reduced- Montage Standard Electroencephalograph OMC
    Standard Polysomnograph With Electroencephalograph OLV
    Ventilatory Effort Recorder MNR

    Proprietary Names

    Zmachine DT-300; Zmachine Synergy

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)