WARN 09/06/96 S&W MEDICO TEKNIK A/S -Patient monitoring
1. The software for the device identified as the Diascope traveller has been modified to add color to the monitor display. This is a very significant change since a new graphic controller (new hardware) had to be used in addition to a new color LCD display and a new set of codes (new software) had to be implemented to take advantage of the new color options. The 510(k) summary for premarket notification K942196 for the device identified as the Diascope NT indicates that the original display is monochrome with only four grey tones.