BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AIRS Medical Inc.

    Reg #: 3024820186 · FEI: 3024820186 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    AIRS Medical Inc.
    Registration Number
    3024820186
    FEI Number
    3024820186
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    13-14F, Keungil Tower, 223, Teheran-ro, Gangnam-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K230854

    Owner / Operator

    Firm Name
    AIRS Medical Inc.
    Operator Number
    10086333
    Address
    475 North Martingale Rd, Suite 710
    City
    Schaumburg
    State
    IL
    Postal Code
    60173
    Country
    US
    Correspondent
    Markus Cho

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    SwiftMR (A20-CL and A22-OP) SwiftMR SwiftSight-Brain SwiftMR(A20-CL/A22-OP) SwiftSight-Hub

    Establishment Types

    Manufacture Medical Device