FDA 510(k) Application Details - K203749

Device Classification Name	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K203749
Device Name	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Applicant	Ambu A/S Baltorpbakken 13 Ballerup 2750 DK Other 510(k) Applications for this Company
Contact	Karina Matthiesen Other 510(k) Applications for this Contact
Regulation Number	868.5740   More FDA Info for this Regulation Number
Classification Product Code	CBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2020
Decision Date	05/03/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review