FDA 510(k) Application Details - K221477

Device Classification Name	Cuff, Tracheal Tube, Inflatable   More FDA Info for this Device
510(K) Number	K221477
Device Name	Cuff, Tracheal Tube, Inflatable
Applicant	Hospitech Respiration Ltd. 15 Atir Yeda Kfar Saba 446312 IL Other 510(k) Applications for this Company
Contact	Yoel Bergman Other 510(k) Applications for this Contact
Regulation Number	868.5750   More FDA Info for this Regulation Number
Classification Product Code	BSK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2022
Decision Date	12/29/2022
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