BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OneRF Ablation System

    Reg #: 3016438686 · FEI: 3016438686 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    NEUROONE MEDICAL TECHNOLOGIES CORP.
    Registration Number
    3016438686
    FEI Number
    3016438686
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7599 Anagram Drive
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231675

    Owner / Operator

    Firm Name
    NeuroOne Medical Technologies Corp.
    Operator Number
    10062284
    Address
    7599 Anagram Drive
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US
    Correspondent
    Chad Wilhelmy

    Products

    Device Name Product Code
    Generator, Lesion, Radiofrequency GXD
    Probe, Radiofrequency Lesion GXI

    Proprietary Names

    OneRF Ablation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198