From the June 2021 4C:You're correct regarding the second part,...

From the June 2021 4C:


You're correct regarding the second part, CDX don't require it - my mistake, I misread it.

SphygmoCor® is FDA-cleared, CE-marked, and approved by China FDA. It is a reimbursable technology, available through a variety of guaranteed EZ acquisition programs. I missed the word "China" who also have the same FDA abbreviation

That being said, I must admit further misunderstanding on my behalf as I thought you could only do the 510k application if you had approval, but it seems to also apply when you have clearance which helps.