FDA 510(k) Application Details - K242921

Device Classification Name	Tube, Tracheostomy (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K242921
Device Name	Tube, Tracheostomy (W/Wo Connector)
Applicant	Vitaltec Corporation No. 12, Lane 4-30, Chyuan-Zhou Rd., Hou-Li Dist. Taichung City 42142 TW Other 510(k) Applications for this Company
Contact	Joseph Chang Other 510(k) Applications for this Contact
Regulation Number	868.5800   More FDA Info for this Regulation Number
Classification Product Code	BTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2024
Decision Date	06/10/2025
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