Thanks @Hercepin - and for including the link. I looked under the Solutions/Clinical pages, but not at the header page!
I tried to get further today with what the standards and procedures are with the NMPA (China's equivalent to FDA). Especially as Mobvoi is China based.
Unfortunately Chinese language websites, translated by Google, are not somewhere to go to clarify points of detail.
If anyone has a Chinese language background, we'd appreciate your help.
In my view, as it stands, the CONNEQT devices will need to undergo clinical trials so they can be submitted for FDA 510k CLEARANCE.
Which is not a big deal - especially given the prior standing of Atcor's SphygmoCor.
BTW: My view on the current SP movements is .... just needs a few weeks to clarify where it is at.
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