My take is NO video No work at this point. Just show what the FDA was sent. The FDA will have no problems with this. There would be little to no cost. The excuse is we are to busy on working on the new 510 K. ????????????????
HS..The FDA said...."(Please note that a 510(K) should not be submitted until the device is in its final state and device testing and validation have been completed). I rest my case...The device is not working and the FDA beleives this to be a fact as well.....