BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ohmega

    Reg #: 3017448360 · FEI: 3017448360 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Registration Number
    3017448360
    FEI Number
    3017448360
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    180 International Drive
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060166

    Owner / Operator

    Firm Name
    Laborie Medical Technologies Corp.
    Operator Number
    10079684
    Address
    180 International Drive
    City
    Portsmouth
    State
    NH
    Postal Code
    03801
    Country
    US
    Correspondent
    Nicole Boser

    Products

    Device Name Product Code
    System, Gastrointestinal Motility (Electrical) FFX

    Proprietary Names

    Ohmega

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device