FDA 510(k) Application Details - K201026

Device Classification Name	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K201026
Device Name	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Applicant	HyTek Medical, Inc. 8741 Shirley Ave Northridge, CA 91324 US Other 510(k) Applications for this Company
Contact	Nir Hoftman 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	04/20/2020
Decision Date	08/10/2021
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