510(k) K190213

Yikang Endotracheal Tube by Jiangxi Yikang Medical Instrument Group Co., Ltd. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2019
Date Received
February 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type