Your post still indicates you don't understand the process...

Your post still indicates you don't understand the process properly. FDA is the US body. Approval in terms of the FDA is only for Class III products.

But thank you for the CDX statement re CONNEQT brand products.

What that statement says is that Cardiex will be able to "provide medically reliable data" in the marketplace.

To do that, they will need to:
(i) run a Clinical Trial
(ii) submit trial results to FDA for 510k CLEARANCE


Can you provide an ASX/CDX link (or snip) that talk about the status of SphygmoCor before we discuss its status? I do not know anything re the Chinese body or its systems.

CE marking is something completely different once again:

I appreciate the conversation, it helps us all to be accurately informed.

...