BEUDAMED
    FDA Registration Active 🇺🇸 United States

    External ECG Connector Cable and Adapter

    Reg #: 3032367 · FEI: 3002087856 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    FUJIFILM SONOSITE,INC.
    Registration Number
    3032367
    FEI Number
    3002087856
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    21919 30th Dr SE
    City
    BOTHELL
    State
    WA
    ZIP
    98021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213763

    Owner / Operator

    Firm Name
    FUJIFILM CORPORATION
    Operator Number
    8031568
    Address
    26-30, Nishiazabu 2-chome
    City
    MINATO-KU
    State
    Tokyo
    Postal Code
    106-8620
    Country
    JP

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Biopsy Needle Guide Kit OIJ

    Proprietary Names

    External ECG Connector Cable and Adapter Sonosite ECG Module Leadwires P5-1 MHz Transducer Sonosite ECG Module Cable, Leadwires, ECG IC10-3 MHz Transducer T8-3 MHz Transducer L12-3 MHz Transducer L15-4 MHz Transducer C10-3 MHz Transducer Sonosite LX Ultrasound System Sonosite PX Ultrasound System L19-5 MHz Transducer C5-1 MHz Transducer Sonosite ZX Ultrasound System Sonosite ST Ultrasound System

    Establishment Types

    Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device