BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST

    K Number: K911116 · Decision Dec 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    9
    Review Days
    288

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    Basic Information

    Device Name
    INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST
    K Number
    K911116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Interson Corp.
    Date Received
    March 7, 1991
    Decision Date
    December 20, 1991
    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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    K911115 INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM
    K911114 INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM
    K911464 INTERSON DISPOSABLE BIOPSY NEEDLE
    K900555 INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.
    K896680 PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.
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