BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zmachine DT-200

    Reg #: 3009770872 · FEI: 3009770872 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CONSOLIDATED RESEARCH, INC.
    Registration Number
    3009770872
    FEI Number
    3009770872
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    26250 Euclid Ave Ste 709
    City
    Euclid
    State
    OH
    ZIP
    44132
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142825

    Owner / Operator

    Firm Name
    Consolidated Research, Inc.
    Operator Number
    10041808
    Address
    26250 Euclid Ave., Suite 709
    City
    Euclid
    State
    OH
    Postal Code
    44132
    Country
    US
    Correspondent
    Richard Kaplan

    Products

    Device Name Product Code
    Standard Polysomnograph With Electroencephalograph OLV
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Reduced- Montage Standard Electroencephalograph OMC

    Proprietary Names

    Zmachine DT-200 Zmachine Insight Zmachine Insight+

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility