Tom, APPY want this approve asap. I believe they will let everyone know something very soon. I expect a PR within a week for the company explaining more in details of their plans.
Tom I did more research and made some phone calls. IMO, it is not APPYl testing device that fail, but the company paperwork with the 510(k)is what imo that caused them the FDA approval. This is an easy fix. They need a pro to handle this if they can't do it correctly. An FDA decision usually take up to 90 days if everything is submitted on time. An appeal could take up to 60 days.
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