510(k) K203749

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable by Ambu A/S — Product Code CBI

K203749 is an FDA 510(k) premarket notification submitted by Ambu A/S for the device "Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable". The FDA issued a decision of Substantially Equivalent on May 3, 2021. The device falls under product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5740. Ambu A/S has at least 10 other 510(k) clearances on record.