If you've submitted a 510k for your medical device, you can advertise it as "510k pending".
There is a risk that you never receive the clearance or approval, but in this case Apple probably knew they had already addressed any feedback the FDA had so it was very likely there would be no further stumbling blocks
There is a risk that you never receive the clearance or approval, but in this case Apple probably knew they had already addressed any feedback the FDA had so it was very likely there would be no further stumbling blocks