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13:06
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Originally posted by Richney
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I don't have to answer that. That is for the FDA to decide and the Company providing the all the information and data that the FDA has requested. You just can't process the fact that the FDA submission for Wheezo is as a 510k Predicate Device. The overuse of "?" wont change that fact and something you can either accept or cease with this line of questioning. Fact - Wheezo FDA Submission as a Class 1 device is as a 510k Predicate Device.
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Which was my point, the FDA couldn't have access to the latest clinical trial result for the new generation algorithm as they weren't supposedly completed before the submission.....maybe as a holder you should contact management to confirm??? I could be wrong but I find this very strange.
