FDA 510(k) Application Details - K192611

Device Classification Name	Cuff, Tracheal Tube, Inflatable   More FDA Info for this Device
510(K) Number	K192611
Device Name	Cuff, Tracheal Tube, Inflatable
Applicant	Biovo Technologies Ltd. 23 HaMelacha St ROsh HaAyin 4809173 IL Other 510(k) Applications for this Company
Contact	Barbara Sokoletsky 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	09/20/2019
Decision Date	08/13/2020
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