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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
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