it's also worth noting that Andon have a good track record of getting 510k clearance ... they know what is needed. The last clearance was in Dec, 2022. FDA has supposedly worked hard to streamline process since the Oscar device in 2015 ( I can see that was 290 days ), but some still seem to drag out well beyond 200 days.
The Arm Blood Pressure Monitor from Andon below cleared in 2019 was 160 days from submission
General Forum, page-817
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