FDA 510(k) Application Details - K190213

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K190213
Device Name	Tube, Tracheal (W/Wo Connector)
Applicant	Jiangxi Yikang Medical Instrument Group Co., Ltd 188 Aihua Road, Jinxian County Nanchang 331725 CN Other 510(k) Applications for this Company
Contact	Nicholas Su 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	02/04/2019
Decision Date	09/06/2019
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