Please stop posting the same question expecting a different answer....go an "think" quietly to yourself as we have made it very clear the FDA process and position however you somehow think that the FDA is going to change its mind based on you seemingly not understanding the regulatory process.
Let's say it again just for AlCP...
Fact - Wheezo FDA Submission as a Class 1 Device is as a 510k submission based on a predicate device.
Ann: Patent application filed - Next Generation wheezo algorithm, page-25
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