510(k) K122932

SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT by Fogless International AB — Product Code JOH

K122932 is an FDA 510(k) premarket notification submitted by Fogless International AB for the device "SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT". The FDA issued a decision of Substantially Equivalent on December 23, 2013. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800.