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Yes, and hopefully they can even manage an abbreviated 510k...

  1. Mcfisty
    275 Posts.
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    26/02/20
    12:32
    Post #: 43161173
    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.
    RAP Price at posting: 20.0¢ Sentiment: Hold Disclosure: Held
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    lightbulb Created with Sketch.  Great analysis
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