Some light reading re. the FDA 510(k) submission process we are currently going through. It looks like we are going to have a fair idea within 60 days if we are getting clearance - with final clearance due within 90 days.
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process?source=govdelivery&utm_medium=email&utm_source=govdelivery
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