Yes the condensation test which is a new requirement due to the Phillips recall.
You stated 510k denied which is not the case, this application is still ongoing and I expect will not take long to get test done and device approved pending result of test.
Denied Implies they have to start 510k process all over again with a new submission, that is not the case.
It’s not that black and white. They need additional testing/ information. It’s neither approved nor denied. It’s in between submitted and approved/denied.
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