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Activaero’s Watchhaler Receives FDA 510(k) Clearance

July 16, 2008

The FDA has issued 510(k) clearance for the Activaero’s Watchhaler spacer, an inhalation system for children with asthma.

The Watchhaler is a reservoir system, or “spacer,” that controls the inhalation flow rate and volume to deliver aerosol to the lungs. It is used with standard metered-dose inhalers and is meant to provide a child-friendly method of delivering treatment.

The product was launched in April 2007 in Europe.