11/06/20 5:36 PM

#239681 RE: 4toSchool #239652

That's correct 4toschool. Per internet explanation:
Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. Those already-cleared products are called a predicate.
So approved or cleared, it would too be correct.