FDA 510(k) Application Details - K083883

Device Classification Name	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K083883
Device Name	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Applicant	PULMONX, INC. 24125 85TH AVE SE WOODINVILLE, WA 98272 US Other 510(k) Applications for this Company
Contact	Roberta Hines 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	12/29/2008
Decision Date	06/25/2009
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