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510(k) Data Aggregation

    K Number
    K960421
    Device Name
    SINUSCAN 102/SINUSPRINT
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1997-04-16

    (443 days)

    Product Code
    LWI
    Regulation Number
    892.1560
    Why did this record match?
    Product Code :

    LWI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oriola Sinuscan 102/Sinusprint device is intended for use in the ultrasound detection of frontal and maxillary sinusitis.
    Device Description
    The Oriola Sinuscan 102/ Sinusprint is a pulsed ultrasound scanner. The Oriola Sinuscan 102/Sinusprint device functions by ultrasonic sending pulses of energy and receiving echoes from acoustic interfaces in the manner of an echo sounder. The reflected echoes are converted to an electric signal and concise on the LCD display and/or printed by the printer.
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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?
    Product Code :

    LWI

    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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    K Number
    K960241
    Device Name
    CPR GENERAL SURGERY TRAY
    Manufacturer
    CUSTOM PACK RELIABILITY
    Date Cleared
    1996-03-22

    (66 days)

    Product Code
    LWI
    Regulation Number
    892.1560
    Why did this record match?
    Product Code :

    LWI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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