BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Hyper Insight

    Reg #: 3035495311 · FEI: 3035495311 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PURPLE AI INC.
    Registration Number
    3035495311
    FEI Number
    3035495311
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 107, 111 on the 8th floor of Hongwoo Building,, 373, Gangnam-daero,
    City
    Seocho-gu, Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K240353

    Owner / Operator

    Firm Name
    Purple AI Inc.
    Operator Number
    10092460
    Address
    Room 107, 111 on the 8th floor of Hongwoo Building,, 373, Gangnam-daero,
    City
    Seocho-gu,
    State
    Seoul
    Postal Code
    06621
    Country
    KR
    Correspondent
    Byungjun Park

    US Agent

    Business Name
    Empirical Technologies
    Contact Name
    Hannah Taggart
    Address
    4628 Northpark Dr
    City
    Colorado Springs
    State
    CO
    ZIP
    80918
    Country
    US
    Email
    [email protected]
    Phone
    719 4571152

    Products

    Device Name Product Code
    Radiological Computer-Assisted Triage And Notification Software QAS

    Proprietary Names

    Hyper Insight

    Establishment Types

    Manufacture Medical Device