BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Disposable Intraoperative Probe (DIOP8)

    K Number: K201425 · Decision Feb 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    388
    Registration Numbers
    389
    Same Product Code
    407
    Applicant Total
    2
    Review Days
    266

    Basic Information

    Device Name
    Disposable Intraoperative Probe (DIOP8)
    K Number
    K201425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huntleigh Healthcare Limited
    Date Received
    May 29, 2020
    Decision Date
    February 19, 2021
    Product Code
    ITX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITX Transducer, Ultrasonic, Diagnostic

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