Stern,
Please review your research on the Company. RSH's clinical product the Wholter, upon which the same ARM (Acoustic Respiratory Monitoring) platform has been used to build the AirSonea and Wheezo has FDA Clearance in addition to the company also holding FDA clearance for their original non-smartphone connected Wheezometer (but it is only cleared for prescription use). All RSH products are built on the same ARM foundation for which the Company can and has lodged the current FDA clearance approval based on a "510k Predicate Device". Stern, the only way this application can happen through the FDA is if a previous version of the device has received FDA and against which the current version can be compared.
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Product tests & clinical results, facts please, page-6
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