Its nice to see an announcment regarding the FDA but this one raises a few questions:
- When does Isonea expect to receive the approval?
- What type of approval will it be? OTC, 510k with prescription, etc.
- If OTC, will this enable a 510k for the airsonea?
- The 'approval' took approximately two years, is a similar timeline expected of Airsonea?
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- Ann: FDA Approval for SonoSentry is Close
Ann: FDA Approval for SonoSentry is Close, page-2
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