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    K Number
    K960044
    Device Name
    ULTRAMAX/MODEL NUMBER A1
    Manufacturer
    ENTLAB OY
    Date Cleared
    1996-08-02

    (213 days)

    Product Code
    LWI
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTLAB OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultramax ultrasonic diagnostic system is intended to assist the physician in the diagnosis of maxillary and frontal sinusitis by detecting fluid in the sinus cavity.
    Device Description
    The Ultramax is an A-scan, pulseecho device, equipped with a single unfocused flat 8 mm 3 MHz transducer. Pulse repetition rate is fixed at 300 Hz. The only controls on the device are the receiver gain, and the range that can be selected between "8" (0-8 cm), " 4 " (0-4 cm) and "4E" (4-8 cm). These selections do not effect the emitted acoustic power.
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