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

    PSF-50ET

    K Number: K910850 · Decision Jan 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    388
    Registration Numbers
    389
    Same Product Code
    407
    Applicant Total
    145
    Review Days
    336

    Basic Information

    Device Name
    PSF-50ET
    K Number
    K910850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
    Date Received
    February 27, 1991
    Decision Date
    January 29, 1992
    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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