ISN 9.09% 6.0¢ isonea limited

"The outcome of an application for over-the-counter sales is...

  1. 35 Posts.
    "The outcome of an application for over-the-counter sales is expected midyear."

    I assume this effects the US launch date of AirSonea

    The FDA turn around for a 510k is 90 days. Does this mean the application has not yet been submitted?

 
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