Opportunity, first of all, Moro has forever been attempting to say RECAF is a class II device. It is Class III. Now as far as a 510k, a predicate is needed that is nearly the same for a device to use that method of approval.
If Moro ever gets a POC device approved with a 510k, I would be most shocked.
As for Constab, I communicated with Moro about them. He said he was much more advanced than they were and he did not want to share anything with them.
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