Yes, and hopefully they can even manage an abbreviated 510k which is a pathway you would use for a major update or feature rather than a new product. For a new product they would be doing a 510k where their own ResAppDx is the predicate device and they are demonstrating that the new product is substantially equivalent. This is a shoe in but still a lot of paperwork compared to the abbreviated 510k pathway.
2020 The Year Of RAP, page-1112
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
-
- There are more pages in this discussion • 244 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)