FDA 510(k) Application Details - K150157

Device Classification Name	Cuff, Tracheal Tube, Inflatable   More FDA Info for this Device
510(K) Number	K150157
Device Name	Cuff, Tracheal Tube, Inflatable
Applicant	HOSPITECH RESPIRATION LTD. 20 HAMAGSHIMIM ST. KIRYAT MATALON PETACH TIKVA 49348 IL Other 510(k) Applications for this Company
Contact	Yoram Levy 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	01/23/2015
Decision Date	02/16/2016
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