510(k) K201082

LTV2 Series Ventilators by Vyaire Medical, Inc. — Product Code CBK

K201082 is an FDA 510(k) premarket notification submitted by Vyaire Medical, Inc. for the device "LTV2 Series Ventilators". The FDA issued a decision of Substantially Equivalent on November 10, 2021. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Vyaire Medical, Inc. has at least 10 other 510(k) clearances on record.