BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

    Reg #: 3008986341 · FEI: 3008986341 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BENCHMARK ELECTRONICS, INC.
    Registration Number
    3008986341
    FEI Number
    3008986341
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 Innovative Way
    City
    Nashua
    State
    NH
    ZIP
    03062
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211818

    Owner / Operator

    Firm Name
    Benchmark Electronics, Inc.
    Operator Number
    10057630
    Address
    100 Innovative Way
    City
    Nashua
    State
    NH
    Postal Code
    03062
    Country
    US
    Correspondent
    Melissa O Sturges

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)