FDA 510(k) Application Details - K182548

Device Classification Name	Cuff, Tracheal Tube, Inflatable   More FDA Info for this Device
510(K) Number	K182548
Device Name	Cuff, Tracheal Tube, Inflatable
Applicant	Tianjin Medis Medical Device Co., Ltd. No. 15-A, Saida One Avenue, Xiqing Economic Development Area Tainjin 300385 CN Other 510(k) Applications for this Company
Contact	Yongzhi Wu 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	09/17/2018
Decision Date	01/25/2019
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