Hi idkm, thanks for all your input. this might cast some light on the USA De Novo. The Bose classification and decision summary is on page 3.
The Bose can be used as a predicate for the 510(k)
"Devices that are classified through thede novoprocess may be marketed and used as predicates for future 510(k) submissions."
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm232269.htm
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