Not good, they're loss, bunch of wankers it's smartphone software for Christ sake!
"additional information is required to demonstrate that the
probable benefits of the device outweigh its probable risks." Nothing but negativity towards our device regarding anything that this company does in the United States. I can't believe that this decision has been made particularly during these elevated times of the coronavirus unleashing havoc throughout the world. Seriously the FDA need to revise this decision. Our company needs to appeal and take this to another level!
I'm disappointed that even though we had experience group backing us up with their 99% track record all of the positive vocabulary from the FDA positive spin from Morgans and still I know go... it's just does not make any sense at all!!! Thankfully we have sleep apnea to fall back onto and clearances already in place in other regions.
Commiserations RAPpers... I will be loading up not selling!!
Cheers
Red bar
Ann: Update on US FDA De Novo Classification Request, page-18
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #