BEUDAMED
    FDA Registration Active 🇺🇸 United States

    nView s1 with nav option

    Reg #: 3016619943 · FEI: 3016619943 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    NVIEW MEDICAL
    Registration Number
    3016619943
    FEI Number
    3016619943
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    550 W 900 S Ste C
    City
    Salt Lake City
    State
    UT
    ZIP
    84101
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211064

    Owner / Operator

    Firm Name
    nView medical
    Operator Number
    10083398
    Address
    2681 E Parleys Way, STE 107
    City
    Salt Lake City
    State
    UT
    Postal Code
    84109
    Country
    US
    Correspondent
    Lisa Last

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    nView s1 with nav option nView s1

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198