I have tried to be a hero and searched the FDA website until I was blue in the face. I would love to confirm if the FDA is involved. IF anybody has time:
I have been searching the FDA data base for the two FDA applications that you have mentioned.
I went to their Premarket Approval Database and put in Cardio Infrared Tech and the device Cardio Cor and the reply was "No records were found for Cardio Infrared Tech - Trade Name Cardio Cor"