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

    SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM

    K Number: K945796 · Decision May 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    78
    Review Days
    177

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    Basic Information

    Device Name
    SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM
    K Number
    K945796
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sharplan Lasers, Inc.
    Date Received
    November 28, 1994
    Decision Date
    May 24, 1995
    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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