Apparently @Yenom23 thinks you need FDA approval otherwise "it’s usually a sub par wanna be", didn't the pervious version of wheezo received FDA approval after CE and TGA approval many years ago as just a class I device so how were the sales then???? Lets hope RSH don't do what they did with their clinical studies for the latest wheezo and use that documentation to support their FDA submission by removing the unbind result of 2 out of the 10 physician data to make the accuracy look okay....
Pardon my Pun, page-35
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