FDA 510(k) Application Details - K190274

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K190274
Device Name	Tube, Tracheal (W/Wo Connector)
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	868.5730   More FDA Info for this Regulation Number
Classification Product Code	BTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2019
Decision Date	07/30/2019
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