510(k) K181524

Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART by Vyaire Medical, Inc. — Product Code BZC

K181524 is an FDA 510(k) premarket notification submitted by Vyaire Medical, Inc. for the device "Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART". The FDA issued a decision of Substantially Equivalent on November 30, 2018. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Vyaire Medical, Inc. has at least 10 other 510(k) clearances on record.