So from my readings the 510k had to be submitted at least 90 days before the product was intended to be released to the market, and clearence is the full tick of approval from the fda for go ahead.
So now the go ahead has come I take it Cortical has pre market stock available ? If so sales could start quite soon as well as the big thumbs up from the fda. This would be a confirmation for phillips that now BARM which fully intergrates with their machine and others is about to be released with a quantifiable sales outlook long into the future. So high potential for an offer on the table in my train of thought.
Am I on the right mark or is something in my brief bit of research so far amiss ?
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- Ann: Cortical secures USA 510(k)
So from my readings the 510k had to be submitted at least 90...
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