FDA was already done in 2014 for the old version- there is no need for FDA "approval" as the product is substantially similar to other products on market, and nothing is ingested- it gets a Substantially Equivalent (SESE) rating.
The Respiri announcement will be exactly the same- if anyone buys on this news they're misinformed... Decision was already public a week ago anyway- you can see it on the FDA website. It's not really a decision anyway...
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act."
