|Trade Name||SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER|
|Classification Name||bone sonometer|
|Generic Name||bone sonometer|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changing the manufacturing calibration software by adding a new specification and test methods that limits the amplitudes of the three different probes which are used for the approved multiple skeletal sites to less than 520mv and normalizes the probes to predefined values of approximately 400mv.