[neurotech1]

They are referring to 510(k) Clearance [0]

> The 510(k) Clearance process is one of two ways by which a medical device manufacturer can obtain approval from the Food and Drug Administration, although legally, a device clearance under this section is not a true “approval.” 510(k) Clearance simply gives the company permission to market its product, based on comparison to a “predicate” [previously approved] device.[1]

Basically, If a somewhat similar device is already on the market, the FDA will clear the new device for the market.

[0] https://www.fda.gov/medical-devices/device-approvals-denials...

[1] https://www.levinlaw.com/fda-510k

[Rssnkgp02]

Excellent, yes - thank you for listing these. EKG devices have been around for a long time, so plenty of predicates for 510(k) pathway.