510(k) K241135

RESPOND(R) Ventilator by Corvent Medical, Inc. — Product Code CBK

K241135 is an FDA 510(k) premarket notification submitted by Corvent Medical, Inc. for the device "RESPOND(R) Ventilator". The FDA issued a decision of Substantially Equivalent on November 13, 2024. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895.