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

    TMI LW-100 PULSED DOPPLER SYSTEM

    K Number: K893861 · Decision Feb 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    256

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    Basic Information

    Device Name
    TMI LW-100 PULSED DOPPLER SYSTEM
    K Number
    K893861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Titronics Medical Instruments, Inc.
    Date Received
    May 25, 1989
    Decision Date
    February 5, 1990
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Titronics Medical Instruments, Inc.

    K Number Device Name
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