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FDA 510(k) Application Details - K140228
Device Classification Name
Tube, Tracheal (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K140228
Device Name
Tube, Tracheal (W/Wo Connector)
Applicant
SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD
7TH FL. JINGUI BUSINESS BUIDLING NO. 982
CONGYUN RD, BAIYUN DISTRICT
GUANGZHOU, GUANGDONG 510420 CN
Other 510(k) Applications for this Company
Contact
MIKE GU
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
01/30/2014
Decision Date
12/18/2014
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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