510(k) K023805

LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 by Laerdal Medical A/S — Product Code CBP

K023805 is an FDA 510(k) premarket notification submitted by Laerdal Medical A/S for the device "LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050". The FDA issued a decision of Substantially Equivalent on February 11, 2003. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Laerdal Medical A/S has at least 10 other 510(k) clearances on record.