BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Breast SPEEDER CX

    Reg #: 3007350713 · FEI: 3007350713 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    QUALITY ELECTRODYNAMICS
    Registration Number
    3007350713
    FEI Number
    3007350713
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6655 Beta Drive Suite 100
    City
    Mayfield Village
    State
    OH
    ZIP
    44143
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142002

    Owner / Operator

    Firm Name
    Quality Electrodynamics
    Operator Number
    10023379
    Address
    6655 Beta Drive, Suite 100
    City
    Mayfield Village
    State
    OH
    Postal Code
    44143
    Country
    US
    Correspondent
    Kathleen Aras

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    Breast SPEEDER CX Grid Holder CX Breast Riser CX

    Establishment Types

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