Ann: HealthLinx Intellectual Property portfolio s, page-6

re: Ann: HealthLinx Intellectual Property por... Thanks lilythepink... on a quick google I also found the extract below. Does this mean they may get to market more quickly ?



510(k) Premarket Notification:
Submitting, on behalf of the medical device manufacturers, 510K notifications to FDA to clear products into the US market.
Many of FDA regulated devices fall under the medium risk (usually class 2), requiring 510k clearance letter PRIOR TO marketing the product in US. FDA's clearance letter is required before any manufacturer can market/sell a medical device in US market (unless the device is exempt). Besides, the 510k clearance letter may also be used as a marketing tool for countries other than the US.