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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
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