510(k) K241366

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) by Dehas Medical Systems GmbH — Product Code CBP

K241366 is an FDA 510(k) premarket notification submitted by Dehas Medical Systems GmbH for the device "QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)". The FDA issued a decision of Substantially Equivalent on October 29, 2024. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Dehas Medical Systems GmbH has at least 1 other 510(k) clearance on record.